Production Machine Operator (Afternoon)
Rochester, MI job
Why Us?
We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
Summary
In accordance with Current Good Manufacturing Practices, Standard Operating Procedures (written and/or oral) instructions and Safety Regulations are responsible for the continuity of complex operations required to maintain production.
Job Description
Key Accountabilities
- key outcomes/deliverables, the major responsibilities, and % of time
Accountability
Responsibilities
% of Time
Operational
Sets-up, checks, adjusts and runs production equipment as required by product and size change over. This requires the PMO to bend, lift, use both hands and have correct 20/20 vision
Communicates effectively and on a timely basis to fill and seal operators
Coordinates with Area Supervisors to ensure an efficient filling operation
Communicates with Supervisor in a proactive manner with respect to line operating conditions, product quality status, and potential improvements
Cleans lubricates, starts, stops and services equipment necessary to promote and maintain a smooth & efficient flow of production
When necessary, performs required environmental and personnel monitoring sampling and recording
Determines and verifies that correct and adequate labels, materials and supplies have been provided to meet production schedules
Maintains a continuous supply of materials to production lines
Notifies Area Supervisor of processes or equipment not in a state of regulatory compliance when discovered
70%
Documentation
Documents all line clearance forms and other documentation forms necessary for the processing of each batch
Records downtime, production output and other manufacturing documents as assigned
10%
Compliance
Maintains eligibility for core qualification
10%
Testing
Integrity tests sterilizing filters
10%
Other
Performs other duties as assigned by Area Supervisor
Continuous
Total
100%
Qualifications
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
High School Diploma, GED or equivalent
Successful completion of in-house training programs (includes Upgrader Exam)
Knowledge
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
Arithmetic Aptitude preferred
Pressure and Temperature Aptitude preferred
Skills
&
Abilities
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing
etc.
Mechanical Aptitude preferred
Hand Tools and Measuring Instruments Aptitude preferred
Physical Requirements
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
Required to reach with hands and arms and frequently required to use hands to finger, handle or feel
Occasionally lift and/or move up to 50 pounds
Specific vision abilities required by this job include close vision
Frequently exposed to moving mechanical parts
Frequently exposed to toxic or caustic chemicals
The noise level is moderate
Work environment is a production/manufacturing environment
EEO Statement:
We firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.
Auto-ApplyDirector, Aseptic Operations - Sterile Fill
Rochester, MI job
Why Us?
We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
Summary
The Director of Operations at the Rochester MI facility leads the establishment, implementation, maintenance and execution of: cleaning, sanitization, and/or sterilization of production equipment and facilities; raw material sampling, dispensing and product formulation; aseptic/sterile primary packaging of liquid, suspension, or lyophilized product in plastic bottles, vials or syringes; inspection, secondary labeling and packaging of the finished product. Work requires excellent teamwork, ability to communicate clearly, and cooperate with other staff members to achieve overall organizational objectives and sustain site's positive performance record associated with Quality Management System (QMS), cGMP and EHS compliance. The individual must have the ability to coordinate work between functions to ensure alignment with overall site Vision, Mission and Execution Strategy.
Job Description
Scope of Authority
- span of control
(work unit, site, department, division, etc.), monetary value of budget/spend authority
( capital, operating, etc.), P&L responsibility, etc.
Span of Control: oversight of five (5) budgetary departments representing seven (7) operational working units: 1) Sanitation, Drug & Chemical Dispensing, Bulk Manufacturing; 2) Preparation Services; 3) Sterile Filling; 4) Inspection & Packaging, and 5) Manufacturing Administration
Operating Budget ~$15M; Spend/signing authority at $25K
Key Accountabilities
- key outcomes/deliverables, the major responsibilities, and % of time
Accountability
Responsibilities
% of Time
Operations
Directs production in Sanitation, Preparation Services, Drug & Chemical Dispensing, Bulk Manufacturing, Sterile Filling, Inspection & Packaging.
Oversees execution of commercial production to meet patient, quality, business, and financial objectives as well as supporting developmental and technical transfer production activities across three shifts.
Maintains proper staffing and training levels to meet requirements.
Provides management reporting through development and use of department metrics aligned with Site Objectives and Scorecard.
Sets priorities to meet internal cycle times and delivery schedules.
Assure adequate maintenance of department machinery and supplies.
Establishes and drives expectations for production schedules & reducing non-value-added waste while meeting weekly delivery schedule and financial objectives.
Participates and develops long-term strategies and risk management programs that increase the compliance, efficiency and effectiveness of operations
20%
Compliance
Develops and maintains a safe manufacturing environment in accordance with plant/corporate policies and with local, state and federal environmental, health and safety regulations. Participates in safety meetings, investigates accidents, expects proper PPE and industrial hygiene controls, and takes appropriate corrective actions to eliminate hazardous conditions.
Promotes a quality and compliance focused culture which embraces RFT (right first time) and CI (continuous improvement)
Assures cGMP compliance with regulatory agencies (FDA, EMA, etc.)
Performs assessments and risk assessments based on business development and new product/process/technical transfer activities associated with employee operations, GMP Compliance and safety.
Lead initiatives for root cause analysis to implement effective corrective actions, reducing the potential for deviations related to human error.
Manage audits and inspections by regulators, corporate office and contract customers by escorting and facilitating information sharing, document review and response commitments.
Directs change controls related to processes, equipment, documentation and safety practices in accordance with Quality System requirements.
20%
Supervisory Responsibilities
Interviews, hires, and ensures training of employees; plans, assigns, and directs work; appraises performance; rewards and redirects employee's activities; addresses complaints and resolves problems.
Develops and trains managers & supervisors for more effective performance in current assignments as well as future leadership roles to meet on-going personnel development and succession planning objectives for continued business continuity.
Secures effective training programs or resources thru partnership with the WorkForce Development Team to support compliance with CFR, OSHA regulations, and manufacturing execution demands.
Assures compliance with procedures, cGMP's regulations, safety, and contract obligations. Reviews documentation produced by management for violations of company policy; recommends disciplinary actions.
Number of exempt employees - direct: 6-8; indirect: 15-25
Number of Hourly employees - indirect: 100-150
20%
Leadership
Establishes expectations, drives accountability & influences effective team building and team work.
Creates an atmosphere of team effort, open communication and inspirational shop floor management.
Interacts productively with peers across all site work streams.
Leads operations managers, supervisors, and hourly staff.
Develops cooperative relationships with contractual bargaining agreement leadership team and colleagues
Meets site objectives in compliance, quality, transformation, employee learning & development, and financial areas.
Supports capital planning initiatives to ensure site remains compliant with local, state and federal requirements.
Sponsors Operational Excellence Program (OEP) improvements as development opportunities for all staff.
Manages special projects as requested/assigned by Executive Team.
40%
Total
100%
Qualifications
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
Direct parenteral manufacturing/quality experience preferred.
Bachelors/Master's degree from an accredited college or university with a major in Science, Packaging Engineering or Business
Six-ten years of progressively responsible work-related experience designing, customizing, managing and evaluating manufacturing operations inclusive of programs to support ongoing personnel development.
Minimum of 10 years supervisory/leadership experience with specific involvement with Operations, Quality and/or Compliance Management. Emphasis on team building, problem solving and employee development inclusive of succession planning.
High level of proficiency in adult education and training, and group presentation
Must be familiar with different approaches to staff and management development using various delivery systems
Skilled in relational databases and ability to use computerized software to support management reporting including word processing, spreadsheets, charts/graphs and presentations
Knowledge
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
Microsoft Office Suite, Quality Management Systems(QMS: Trackwise, LMS, LIMS), Enterprise Resource Planning (ERP) Systems, Calibration Maintenance Management Systems (CMMS)
CFR 210, 211, 610, Part 11, and Parenteral Manufacturing Guidance (FDA/EU Annexes)
Skills
&
Abilities
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing
etc.
Managing People - Includes staff in planning, decision-making, facilitating and process improvement; Takes responsibility for subordinates' activities; Makes oneself available to staff; Provides regular performance feedback; Develops subordinates' skills and encourages growth; Solicits and applies customer feedback (internal and external); Fosters quality focus in others; Improves processes, products and services.; Continually works to improve supervisory skills.
Leadership - Exhibits confidence in self and others; Inspires and motivates others to perform well; effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.
Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.
Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.
Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
Strategic Thinking - Develops strategies to achieve organizational goals; Understands organization's strengths & weaknesses; Analyzes market and competition; Identifies external threats and opportunities; Adapts strategy to changing conditions. Excellent communication skills, including the ability to speak clearly and persuasively in all situations, listen and gain clarification, respond well to questions and write clearly and informatively
Ethics - Treats people with respect; Keeps commitments; inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity.
Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals.
Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.
Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.
Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals. Completes tasks on time or notifies appropriate person with an alternate plan.
Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.
Skilled and Determined - Committed to removal of the eight non-value-adding wastes: Overproduction: Producing product or operating processes where orders do not exist; Waiting: Workers standing around and waiting for the next process step or a process to commence; Unnecessary transport: Carrying Work In Process (WIP) long distances and/or in a “back and forth” repeated manner; Overprocessing: Taking unneeded steps to process the product; Excess inventory: Excess Raw Material, WIP, or Finished Product leading to exaggerated cycle times, obsolescence and storage costs; Unnecessary movement: Any wasted motion of workforce to produce product or operate a process; Defects: Production of defective and/or non-usable products; Unused employee creativity: Loosing time, ideas, skills and improvements by not engaging and/or listening to our employees.
Passion for Right First Time (RFT) Processing
Physical Requirements
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
Stand, walk, sit, lift, talk and hear in office, laboratory and manufacturing work areas
Frequent walkthroughs of shop floor operations
Disclaimer:
The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
EEO Statement:
We firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.
Auto-ApplySterile Area Operator (Afternoons)
Rochester, MI job
Why Us?
We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
Summary
In accordance with written or oral instruction, cleans sterile and non-sterile areas. Operates auto scrubber, floor buffing machines, and carpet extractors. Mixes chemicals and operates fogging equipment.
Job Description
Cleaning
Operates all equipment in the department for the purpose of cleaning and disinfecting/sanitizing/fogging aseptic and non-aseptic GMP areas
Maintains supplies and work area in a clean and orderly fashion
Receives supplies in area and moves to designated storage area
Checks equipment and work area; notifies supervisor when repairs are needed
Collects sterile and non-sterile garb. Separates, counts and moves to designated area. Stocks sterile and lint-free garb areas
Maintains respirators, clean after use and store properly
Disposes of trash and waste properly
Flushes, cleans, and documents safety showers and eye washes. Reports any malfunction to supervisor
Prepares sanitation solutions, such as acids, solvents, detergents, solvents, disinfectants, etc., used to perform cleaning of aseptic and non-aseptic areas
Cleans and properly stores cleaning equipment
60%
Operational
Operates washers, cappers and other equipment within the Sterile Filling Department.
Packs-off product into trays and cases which may require lifting weights of up to 35 lbs.
Evaluates finished product as required.
Maintains a smooth flow of production and monitors equipment as assigned.
Elevates any equipment or process deviations.
Performs other duties as assigned by supervision.
Maintains supplies and work area in a clean and orderly fashion.
Maintains supplies in the controlled areas.
Checks equipment and work area and notifies supervisor if repairs are needed.
Cleans and properly stores waste containers for sterile filling production waste.
30%
Documentation
Documents GMP records, LUMAC logbooks and sanitation schedules, upon completion of daily work performed; updates room status
Proactively communicates with area supervisor correcting documentation deficiencies and expediting the corrective process
10%
Compliance
Performs all functions and ensure compliance with Standard Operating Procedures, Good Manufacturing Practices and Corporate Regulations
Observes all safety and health regulations
Continuous
Other
Operates equipment or performs duties as defined within the labor grade or lower labor grades within the LG9-LG10-LG11 upgrader path. Rotates on assignments to all positions within the upgrader path for ergonomic safety.
Assists in training of new colleagues on job
Maintains training requirements in assigned curricula
Maintains eligibility to be Aseptic Core qualified and Media qualification.
Continuous
Total
100%
Qualifications
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
High School Diploma, GED or equivalent
Successful completion of certified in-house qualification programs
Willingness to continue on-going training as required by departmental objectives
Must be aseptically area qualified; must maintain qualifications. If qualification or requalification requirements are not maintained, an employee LG reduction or disqualification may occur.
Knowledge
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
Basic understanding of manufacturing or packaging operations, as applicable
Basic knowledge of industry practices and standards; able to apply basic principle, theories, and concepts
Able to understand & comply with all current state, federal and local standards and regulations, e.g., cGMP, OSHA, EEOC, EPA, FDA and DEA.
Skills
&
Abilities
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing
etc.
Able to prioritize work & multi-task
Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals.
Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.
Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.
Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.
Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals. Completes tasks on time or notifies appropriate person with an alternate plan.
Physical Requirements
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
Required to reach with hands and arms and frequently required to use hands to finger, handle or feel
Occasionally lift and/or move up to 50 pounds
Specific vision abilities required by this job include close vision
Frequently exposed to moving mechanical parts
Frequently exposed to toxic or caustic chemicals
The noise level is moderate
Work environment is a production/manufacturing environment
Routine entry into a manufacturing environment that requires garbing in and out of environmentally controlled areas up to ISO Grade 5; must maintain access.
EEO Statement:
We firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.
Auto-ApplySr./System Account Executive - U of Michigan Health Account
Ann Arbor, MI job
The System Account Executive (SAE) is a specialist role responsible for pull-through of the account plan (developed by the Account Manager) at the Health System´s various sites of care and with the Health Systems Affiliated HCPs. The SAE is also responsible for the delivery of brand value propositions to affiliated Health Care Professionals (HCPs) and generating advocacy for BI products with Key Decision Makers in the system and delivering brand sales growth with the targeted HCPs and accounts. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies´ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees.
Duties & Responsibilities
Increase sales: Generates advocacy with key experts in high control priority health systems.
Utilizes clinical and product knowledge, consultative selling skills, and the assigned Health Systems' business model, objectives, and patient flow in order to support the use of BIPI promoted products.
In addition, the SAE will seek to appropriately increase recognition, diagnosis and treatment rates within BIPI marketed disease state.
Establishes and maintains communication/collaboration/coordination with co-promotion partners and BIPI employees.
Account Plan Pull-Through: SAE will be responsible for contributing to the development of the Account Plan, understand and pull through the Account Plan along with the Health System Marketing strategies.
Delivers value to customers using insight, business analysis, problem solving and flexibility with a focus on opportunities, threats, and trends.
Provides appropriate disease state and other relevant approved presentations to Health System staff as well as other qualified medical personnel as determined by account plans.
The SAE has accurate and timely follow-up discussion with key internal account team members and external stakeholders.
Uses approved account management techniques to facilitate the decision-making process and engagement.
Supports the Health Systems' Triple Aim efforts in various care settings to include appropriate pull through of protocols, pathways, order sets, formularies, treatment algorithms, transition of care, and population health management initiatives to assist the Health System with the delivery of optimal care.
Aware of top plans for the priority Health System and key stakeholders. Engages the appropriate key stakeholders in discussions on the payer environment, copays, and formulary access.
Supports products on Payor formularies.
Works in concert with an extended team to pull-through MCO decisions.
Analyzes territory information to optimize Health System and key stakeholder interactions.
Is knowledgeable of barriers and opportunities that impact business and promptly informs account team of any developments.
Is aware of opportunities that meet both Health System needs as well as account plans and brand tactics.
Utilizes CRM and supporting analysis of account plans to guide interactions and monitor appropriate Value Proposition use.
Successfully completes all Sales Training requirements.
In conjunction with other field sales teams, assists in identification of thought leaders, innovators and advocates within the priority Health System. Manages programs, initiatives and budgets to stay within standards.
Builds networks among advocates and key stakeholders within the Health System.
Performs all Company business in accordance with all regulations (e.g., EEO, FDA, DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company policy and procedures.
When violations are noted/observed they are to be immediately reported to management.
Demonstrates high ethical and professional standards with all business contacts in order to maintain BIPI's excellent reputation within the medical and pharmaceutical community.
This is a dual-level posting. Candidates will be hired at the level commensurate with their experience and business need.
Requirements
This is a dual level posting. Candidates will be hired at the level commensurate with their experience and business need.
Systems Account Executive Requirements
* Bachelor's degree from an accredited institution required. Master's degree from an accredited institution preferred.
* A minimum of four (4) years successful pharmaceutical sales experience, or equivalent.
* A minimum of two (2) years successful account management experience preferred.
* Successful sales performance history.
* Ability to travel up to 75% depending upon geography.
* Knowledge across portfolio is preferred.
* Strong understanding of managed care and its impact on the industry.
* Excellent judgment and problem-solving skills.
* Ability to foster ongoing interactions and partnerships with targeted Organized Customer Stakeholders in the execution of account plans.
* Demonstrates acceptable level of performance in current role.
* Proficiency in Excel, Word, Outlook, and database applications.
* Ability to travel (may include overnight travel).
* Should reside in territory geography or be willing to relocate.
* Valid Driver's License and an acceptable driving record.
* Authorization and ability to drive a Company leased vehicle or authorized rental vehicle.
* Strong understanding of managed care environment and intricacies of health systems of varying size, control and willingness to partner.
* Previous account management experience.
* Various regulations (e.g., EEO, FDA, DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company policy and procedures.
Sr. Systems Account Executive Requirements
* Bachelor's degree from an accredited institution required. Master's degree from an accredited institution preferred.
* A minimum of seven (7) years successful pharmaceutical sales experience, or equivalent.
* At least three (3) years of experience in the relevant accounts within the territory is preferred.
* Successful sales performance history.
* Ability to travel up to 75% depending upon geography.
* Knowledge across portfolio is preferred.
* Strong understanding of managed care and its impact on the industry.
* Excellent judgment and problem-solving skills.
* Ability to foster ongoing interactions and partnerships with targeted Organized Customer Stakeholders in the execution of account plans.
* Demonstrates acceptable level of performance in current role.
* Proficiency in Excel, Word, Outlook, and database applications.
* Ability to travel (may include overnight travel).
* Should reside in territory geography or be willing to relocate.
* Valid Driver's License and an acceptable driving record.
* Authorization and ability to drive a Company leased vehicle or authorized rental vehicle.
* Strong understanding of managed care environment and intricacies of health systems of varying size, control and willingness to partner.
* Expertise in account management and knowledge of territory.
* Regulations such as EEO, FDA, DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company policy and procedures.
Associate Director/Director, Medical Science Liaison - Oncology, Central Region (Field-based)
Ann Arbor, MI job
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
The Associate Director/Director, MSLs is responsible for the leadership, direction and management of MSLs in the region and works collaboratively with the Medical Affairs Senior management with strategic and tactical planning, working collaboratively with Medical Affairs and Clinical Development teams for support of clinical studies across the product portfolio. Works closely with his/her direct reports in the field, Medical Directors and at times with external customers to gain an understanding of the scientific landscape and to communicate the information to key internal stakeholders. Provides all direct reports with an individualized view of their development plans and ongoing performance. Assists other managers with leadership competency criteria including performance management assessments of their MSLs and recommendations of promotions Creates a culture of accountability by personally delivering on work commitments, holding others accountable for their performance and by taking, timely, decisive and constructive actions to address individual MSL performance problems and issues.
Essential Functions
* Ensure operational excellence of the MSL team, including corporate aligned objective/tactics, cross-functional medical support, and interactions with key opinion leaders.
* Provide leadership for the MSL function by participating on cross functional teams leading to strategic planning and working collaboratively with Commercial colleagues including, Sales and Marketing as well as Medical Affairs.
* Developing individual talent within the MSL region, including training, career evaluation, coaching, mentoring, performance management and talent review.
* Ensure compliance with regulatory and other ethical guidelines relevant to the pharmaceutical industry, and to ensure compliance with Eisai policies & procedures and standard operating procedures.
* Manage MSL activities related to presenting medical and scientific information to external customers, including but not limited to, medical thought leaders, academic institutions and managed care organizations.
* Assist with recruiting, interviewing hiring, and on-boarding new MSLs.
* Travel (up to approx. 50%), locally across the US when required and including international travel.
Requirements
* Advanced scientific terminal degree (MD, PhD, PharmD)
* Must have a minimum of 5 years of experience within the pharmaceutical industry overseeing a Medical Science Liaison team or related function.
* Excellent interpersonal, communication, and management skills required.
* Strong personal integrity and customer focus are necessary.
* Ability to work at a distance to maintain morale of field based personnel, as well as good interaction with office based Medical Affairs and PCU scientific staff.
* Must possess a thorough understanding of the FDA, OIG, HIPPA, PhRMA, GCP and other international regulatory/ethical guidelines relevant to the pharmaceutical industry & clinical trial conduct, and to ensure compliance with these external as well as internal Eisai guidelines and standard operating procedures.
* Must be able to organize, prioritize, and work effectively in a constantly changing environment.
* Ability to interface effectively with a variety of technical platforms for recording of external interactions and for the collection, review, and dissemination of medical information.
As a condition of employment and an essential function of this field-based position, applicants must be able to engage in person with HCPs and other third parties at their offices, institutions and other appropriate locations on a regular basis. In order to gain in-person access, applicants selected for the position may be required to complete third parties' credentialing and/or entry requirements, which often include an attestation to and/or providing proof of having received certain vaccinations. To the extent you are unable to meet certain requirements for qualifying medical (including pregnancy-related) or religious reasons, applicants must request a reasonable accommodation by contacting the Human Resources Department.Skills:Communication & Cross-functional Influence, Critical Thinking & Agility, Healthcare Environment Dynamics, KOL/ HCP Engagement, Medical Data and Insights, People Development, Resource Planning & Management, Territory Management (MSL)
Eisai Salary Transparency Language:
The annual base salary range for the Associate Director/Director, Medical Science Liaison - Oncology, Central Region (Field-based) is from :$198,900-$261,000
Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan.
Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.
Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit **********************************************************
Certain other benefits may be available for this position, please discuss any questions with your recruiter.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
Right To Work
E-Verify Participation
Auto-ApplyCenter Supervisor
Detroit, MI job
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers.
About the role:
Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. You will report to the Center Manager and oversee the general management of employees assigned to the production areas.
BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd.
How you will contribute:
You will oversee employee performance and scheduling
You will lead Inventory Control efforts and lead in operational efforts
You will work with donors to resolve concerns
You will analyze opportunities specific to non-conforming events
You will perform all tasks for Medical History, Phlebotomy, and Sample Processing areas.
You will foster teamwork, communicate and resolve conflicts.
What you bring to Takeda:
High school diploma or equivalent
Cardiopulmonary Resuscitation (CPR) and AED certification
Frequent bending and reaching
Ability to walk and stand for entire shift, frequent lifting to 32 pounds and occasional lifting to 50 pounds
Fine motor coordination, depth perception, and ability to monitor equipment from a distance
Because of potential exposure to bloodborne pathogens, pro-longed glove wear is required
What Takeda can offer you:
Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include retirement benefits, medical/dental, family leave, disability insurance and more, all in a fast-paced, friendly environment.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to bring Better Health and a Brighter Future to people around the world.
BioLife Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - MI - Detroit
U.S. Hourly Wage Range:
$19.00 - $24.20
The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsUSA - MI - DetroitWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Job Exempt
No
Auto-ApplySr. AD, Health Systems - Great Lakes
Detroit, MI job
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
The Senior Associate Director, Health Systems Business Management is responsible for the management of their assigned Health System Specialists. The position will direct the Health System Business Specialists in the implementation of the BIPI sales/marketing and account plans to assure maximum distribution and market penetration of BIPI and co-promoted products within BIPI guidelines, policies and directives. This role works closely with the KAM to oversee the account planning process.
The Senior Associate Director, Health Systems Business Management works in conjunction with the RAE where applicable to support formulary and Payer Team initiatives. The incumbent ensures equal and consistent application of established policies and procedures in the management of employees to meet or exceed sales goals.
**Duties & Responsibilities**
+ Develops, enhances, and increases BIPI district organized customer account sales performance to meet or exceed annual Company sales and market share objectives.
+ Implements a strategic plan supporting the execution of the account plans through the HSBS.
+ Exercises fiscal control on allocated operating budgets.
+ Recruits and selects Top Talent applicants from a pool of highly qualified diverse candidates to ensure all allocated positions are filled.
+ Proactively develops pool for HSS talent.
+ Effectively administers salary and reward programs.
+ Retains talent with demonstrated successful performance results.
+ Applies appropriate coaching styles to each direct report that motivates high performance and ensures accountability.
+ Provides regular, candid and timely feedback which is documented in Coaching for Excellence and MAG Plans.
+ Ensures all direct reports have actionable Development Plans that grows talent for increased responsibility.
+ Acts early to identify performance challenges or deficiencies and creates plans to appropriately address performance gaps.
+ Works in close partnership with Regional Director and HR, to guide all disciplinary action in the District, up to and including terminations.
+ Analyzes and evaluates the performance of the district.
+ Cultivates teamwork by participating in cross-functional, Regional & HQ meetings to develop district business and account plans and utilizes appropriate data sources to develop district tactical plans.
+ Manages district at a high level of productivity.
+ Facilitates cross-district communications, projects and activities.
+ Plans and executes district meetings that effectively implement objectives and strategies as determined by the Company.
+ Acts as the customer channel expert for his/her district and models sales excellence to their direct reports.
+ Spends appropriate amount of time developing customers, networks and their relationships to foster Company business.
+ Responds to the needs of the customer in a timely and professional manner.
+ Develop a highly integrated district business plan and contributes to the development of the zone business plans.
+ Develops positive and mutually beneficial relationships with Company internal customers, with key accounts in all classes of trade and with BI's co-promotion partners to meet all assigned Company sales goals.
+ Performs all Company business in accordance with all regulations (e.g., EEO, FDA, DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company policies and procedures.
+ Immediately reports noted/observed violations to management.
+ Demonstrates high ethical and professional standards with all business contacts to maintain BI's excellent reputation within the medical and pharmaceutical community.
+ Communicates candidly with supervisor and direct reports.
+ Ensures an open communication environment for direct reports.
+ Applies appropriate coaching styles to each direct report to develop skills and ensure accountability.
+ Possesses ability to assess organizational change management needs and applies appropriate tools to manage change impact within respective organizational groups to ensure successful implementation.
+ Develops a focused Vision and create a high-performance team environment which values continued professional development and personal accountability.
+ Eliminates barriers and fosters a solutions oriented winning vision throughout the district.
+ Exhibits both a long-term, strategic view of the business with an acute focus on driving immediate results.
**Requirements**
+ Bachelor's degree required.
+ A minimum of eight (8) years successful pharmaceutical sales experience, or equivalent.
+ At least three (3) years of experience in the relevant accounts within the territory is preferred.
+ Completion of MDC and a Tier 1 rating OR a minimum of two (2) years successful pharmaceutical District Manager experience required with experience in the geography strongly preferred.
+ Detailed understanding of Organized customer Groups highly preferred.
+ History of successful performance including the last two performance reviews.
+ Demonstrates acceptable level of performance for all District Manager competencies as defined in the On Track to Success Competency Model.
+ Proficiency in Excel, Word, Outlook, and database applications.
+ Ability to travel (may include overnight travel).
+ Should reside in territory geography or be willing to relocate.
+ Valid Driver's License and an acceptable driving record.
+ Authorization and ability to drive a Company leased vehicle or authorized rental vehicle.
**Eligibility Requirements** :
+ Must be legally authorized to work in the United States without restriction.
+ Must be willing to take a drug test and post-offer physical (if required).
+ Must be 18 years of age or older.
All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
Maintenance Mechanic (MM)-1
Rochester, MI job
Why Us?
We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
Summary
Uses skills and abilities to install, inspect, assemble, troubleshoot, repair, adjust, calibrate, constructs, and maintain equipment, parts, and facilities. Documents activities.
Job Description Summary
Job involves using machines like lathes, grinders, and milling machines to cut, shape, fabricate, repair or modify different materials including stainless for precision equipment. You must be able to read technical drawings and blueprints to create exact parts to within a few thousandths of an inch.
REQUIRED QUALIFICATIONS:
Toolmaker or Machinist Journeyman card or Machinist certification through the Military
Minimum of 4 recent years of journeyman experience within the trade
Read and interpret equipment manuals and blueprints and CAD Drawings
Adhere to safety regulations and maintain clean and orderly work areas.
Work in a cleanroom environment.
The ability to use lathes, grinders, and milling machines.
ROLE AND RESPONSIBILITIES:
Inspect machinery and equipment to detect faults and malfunctions.
Ability to identify broken parts, disassemble, fabricate and reassemble parts.
Perform preventive maintenance on cleanroom equipment and machinery.
Perform emergency troubleshooting and repairs when breakdowns occur
Diagnose and repair mechanical problems including issues with hydraulics, pneumatics, and electrical systems.
Test fixed machinery to ensure proper performance.
Implementing machinery upgrades and modifications as needed.
Documenting daily maintenance and repair activities.
Coordinating with team members and other staff to optimize performance.
Recommending improvements to enhance reliability and safety.
Education & Experience
Preferred: Experience and/or training related to pharmaceutical or similar equipment, facilities, and documentation.
Appropriate college degree for tool maker or machinist.
Military machinist or tool maker certification, verifiably with military training records and DD214.
Knowledge
To be eligible for this position, journeyman status or equivalent in the trade or specialty designated by management as currently necessary is required. Experience or education must establish knowledge and ability to perform the technical, reading, documentation, and mathematical requirements of the job.
PHYSICAL REQUIREMENTS:
Required to reach with hands and arms and frequently required to use hands to finger, handle or feel.
Occasionally lift and/or move up to 50 pounds
Specific vision abilities required by this job include close vision
Frequently exposed to moving mechanical parts
Frequently exposed to toxic or caustic chemicals
The noise level is moderate
Work environment is a production/manufacturing environment
ADDITIONAL INFORMATION:
Under contract agreement between Par Pharmaceutical and USW Local 176
EEO Statement:
We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Auto-ApplyOncology Territory Manager, Hematology and Supportive Care - Detroit
Detroit, MI job
Join a Legacy of Innovation 125 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Summary:
The Oncology Territory Manager represents Daiichi Sankyo to assigned customers. The Oncology Territory Manager represents the assigned product(s), and their approved indications, providing approved disease state and product information, and resources to physicians and other customer stakeholders.
Responsibilities:
Achieves or exceeds sales objectives through promotion of product features and benefits to our key accounts:
Academic Institutions, Hospitals, Infusion Centers, Hematologists, Hospitalist, Bone Marrow Transplant members, buying groups, distributors and wholesalers in assigned territory.
Builds relationships with our customer base and key opinion leaders by personally visiting them, educating and influencing physicians and healthcare providers to prescribe Daiichi Sankyo, Inc.'s promoted products. Communicates in a fair and balanced way, products' approved indications, advantages, features and benefits in both individual and group settings.
Analyzes customer needs and interests. Maintains a current key customer target list, submits regular updates to the customer database and plans calls to meet goals. Carries out all sales and marketing programs. Maintains frequent correspondence with District Manager, co-promotion team members, CARE team members and counterparts across the district and region.
Complies with applicable laws in providing healthcare providers with accurate information concerning Daiichi Sankyo, Inc.'s products.
Participates in assigned training and completing outside reading. Keeps abreast of the products, applications, technical service, market conditions, competitive activities, advertising, and promotional trends through the reading of pertinent literature and consulting with colleagues. Attends and participates in all required meetings and training programs.
Serves as a disease state expert and provides a high level of product expertise and customer service for all accounts.
Maintains all equipment and territorial records in the prescribed manner. Utilizes sales force automation system and other equipment to enhance impact of sales call and territory management. Reviews territorial reports with District Manager and learns how to use reports and databases as instruments to achieve assigned goals. Submits complete reports, on-time, and communicates matters that are relevant to the marketplace, competition and the marketing team to the District Manager.
Notifies the Medical Affairs Pharmacovigilance immediately of any product complaints as per SOP 805.21, Reporting Adverse Events (AEs) and Product Quality Complaints (PQCs).'
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university):
Bachelor's Degree required
Experience Qualifications:
4 or More Years overall pharma or healthcare related experience required
1 or More Years sales/marketing experience in the pharmaceutical or medical industry required
specialty, rare disease, and/or oncology experience strongly preferred
experience selling in complex environments preferred
Additional Qualifications:
Must be able to travel up to 60%
Must have a valid driver's license with a driving record that meets company requirements
Compensation and seniority level/title based on experience and qualifications
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law
.
Salary Range:
$126,000.00 - $189,000.00
Download Our Benefits Summary PDF
Auto-ApplyAdvanced Surgical Consultant - Detroit
Detroit, MI job
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
MedTech Sales
Job Sub Function:
Technical Sales - MedTech (Commission)
Job Category:
Professional
All Job Posting Locations:
Danvers, Massachusetts, United States of America, Detroit, Michigan, United States
Job Description:
About Cardiovascular
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.
Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech
This is a field-based role located in Detroit, MI in the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.
We are searching for the best talent for Advanced Surgical Consultant.
Purpose: Heart Recovery, a rapidly growing medical device company, is looking for a driven and results oriented Surgical Sales "Heart Team" Specialist. We are growing both our focus and device line-up in order to support Cardiac Surgeons and Heart Failure Cardiologists across the US. With our continued success, we are looking to expand our commercial team. You will work closely with our Surgical Account Managers and Commercial Sales and clinical team who will be responsible for driving growth across the US. Through our Impella product portfolio you will enable physicians and staff to recover hearts and save patients' lives.
You will be responsible for:
* Train, educate, and support combined CT/Heart Failure programs on the proper use of the Impella.
* Full customer immersion (ie. input on patient selection and subsequent surgical support) within 5.5 sites to ensure optimal patient outcomes.
* Device expertise and support on Impella to assist with the adoption of the full portfolio beyond 5.5 commercial launch responsibilities.
* Surgical implant and unit support readiness including training and education at existing sites.
* Internal collaboration with the Surgical Leadership Team, Training Team, Engineering Team, Marketing, Professional Education, Clinical, as well as with R&D.
* Participate in On Call support rotation
* Maintain contact with all customers to evaluate clinical and educational needs.
* Performs device training on full Impella Device line-up.
* Be a functional expert and provide advanced acumen on the durable, acute, and hemodynamic medical device landscape and best practices in the management of those devices.
* Cultivates close relationships with strategic business partners and key opinion leaders.
* Call point(s): Cardiac Surgeons, Heart Failure Cardiologists, OR teams, Intensivists, Perfusionists, and ICU/ Step Down Unit teams.
Qualifications / Requirements:
* Bachelors' Degree required; Registered Nurse First Assist (RNFA), Nurse Practitioner (NP), Surgical Physician's Assistant (PA), or Perfusionist licensure
* Direct (at the table) experience in Cardiac Surgery/Perfusion, 5+ years preferred.
* Direct patient management experience in one of the following scenarios: a cardiothoracic ICU caring for post-op tMCS (excluding IABP) or durable MCS (does not include experience as an Abiomed field clinical), or direct experience assisting in the CVOR required.
* Confidence, expertise and, familiarity of cardiac surgery and OR protocol is required.
* Willingness to travel/ cover multiple geographies required.
* Up to 50%-overnight travel may be required depending on territory.
* Previous experience with Abiomed Impella 5.5 required; other Cardiac medical devices highly desired.
* Ability to drive patient outcomes required.
* Conduct duties and responsibilities in accordance with all state and federal laws and regulations governing the medical device industry required.
* A valid driver's license issued in the United States is required.
The base pay for this position is $125,000. The Company maintains a highly competitive sales incentive compensation program. Under current guidelines, this position is eligible for participation in this program in accordance with the terms of the applicable plan.
This position is eligible for a company car allowance through the Company's FLEET program.
Benefit Information:
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short and long-term disability, business accident insurance, and group legal insurance.
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
* Vacation -120 hours per calendar year
* Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
* Holiday pay, including Floating Holidays -13 days per calendar year
* Work, Personal and Family Time - up to 40 hours per calendar year
* Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
* Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
* Caregiver Leave - 80 hours in a 52-week rolling period 10 days
* Volunteer Leave - 32 hours per calendar year
* Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to:
* *********************************************
This job posting is anticipated to close on 11/28/2025. The Company may however extend this time-period, in which case the posting will remain available on *************************** to accept additional applications.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.
Auto-ApplySupvervisor, Sterile Filling (Afternoons)
Rochester, MI job
Why Us?
We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
Summary
The Supervisor, Sterile Filling is responsible for daily coordination and execution of working schedules of people and equipment in Sterile Filling. Responsible for supervising hourly union operators that conduct primary filling, lyophilization and/or terminal sterilization of a variety of drug and biological products, including Par branded, development & generic as well as contract customer products while meeting department quality, safety, delivery and productivity objectives. Responsible for direct supervision of one or more aseptic filling lines. Typically this will involve 3 to 6 operators per line. Supervisors are highly knowledgeable in cGMPs and good aseptic practices; must be skillful at communicating, teaching, and inspiring colleagues to a high level of performance. Responsibility requires a high level of documentation, investigative writing, production planning and labor utilization skills. Reviews and releases batch record documentation; completes yield transactions or component returns. Ensures people and processes comply with Good Manufacturing Practices, company procedures, and the union contract. Initiates, and/or reviews department standard operating procedures to support business and quality objectives. Establishes and maintains cooperative cross-functional relationships with peers and leadership in Quality, Operations, Process Development, and Supply Chain to meet plant objectives.
In partnership with the site leaders sponsors a quality and compliance focused site culture which embraces RFT (right first time) and CI (continuous improvement) expectations.
Job Description
Scope of Authority
-
Supervisor of Sterile Filling operations at Rochester, MI manufacturing plant; personnel across one shift
Security-sensitive (highly sensitive) position under the Controlled Substance Abuse Practice
Significant Equipment includes: Washers, Depyrogenation Tunnels, Vial/Syringe/Bottle Fillers, Cappers, Lyophilizers, and Terminal Sterilizers
Key Accountabilities
Operations
Oversees hourly operators in execution of daily work; assures operators comply with validated parameters and standard operating procedures
Develops daily/weekly department work schedules, set priorities and verifies availability of resources
Responsible for schedule adherence; participates in scheduling meetings with the objectives of increased resource utilization
Responsive to changes in daily workflow and schedule; determines needs and redeploys resources and/or overtime to achieve delivery and customer service commitments; adapts to ebb/flow of production process including changes due to unplanned maintenance or events requiring investigation
Ensure all equipment is working properly
Reviews batch records and supporting records prior to submission to Quality
Maintains a safe work environment
Completes in-process, set up checks and verification in alignment with Standard Operating Procedures
20%
Compliance
Understands and adheres to good documentation practices (GDP)
Executes Quality Management System assignments (CAPA, Deviation, Change Control, Standard Operating Procedures etc.) to on-time closure
Obtains knowledge and executes assignments in QMS areas: deviation management and/or change control
Conducts investigations for cause, determines corrective action, and impact; writes reports and assures timely closure
Initiates and executes change control assignments in support of continuous improvement initiatives for equipment, documentation, or processes
Initiates and approves maximo work orders for equipment repairs or modifications
Creates, reviews and conducts operator training programs and assures operator training is conducted on SOPs, cGMP, and safety
Assure and assist classroom and hands on training for batch records, SOP's, and cGMP's, and maintain proper documentation to ensure compliance
Follow and comply with company Safety policies and OSHA Regulations
Participates in development & maintenance of a safe manufacturing environment. Establishes methods in compliance with regulatory, plant, and corporate policies. Participates in safety meetings, investigates accidents, and takes appropriate corrective action to eliminate hazardous conditions
25%
Supervisory
Reports production updates and schedule changes to team and/or at daily Huddle or SMART meetings
Assures hourly operators comply with all procedures, GMP regulations, safety, and contract obligations; provides constructive operator feedback
Assigns manpower; initiates documentation of violations and disciplinary action with operators as required
Requests equipment and facility repairs, or modifications
Understands and complies with Union Agreement
Keeps manager informed of operations; elevates as needed
25%
Leadership
Reviews operational performance; drives improvement opportunities
Counsels, trains, and develops union colleagues for efficient performance; creates an atmosphere of team effort & open communication
Consistently communicate, follow and enforce SOP's and company policies and guidelines set forth in the employee handbook
Troubleshoots or resolves issues impeding department daily/weekly objectives/deliverables; proactively demonstrates the ownership to achieve
Interfaces with suppliers of equipment or products and area consultants/experts
Conducts/supports CMO audits or regulatory agency inspections
30%
Total
100%
Qualifications
Education & Experience
Education
Required- B.A. /B.S. Degree in Science, Business or related field or significant experience
Desired- B.A. /B.S. Degree in Packaging, Science and/or Management degree
Experience
Required - None
Desired - 1-3 years in Pharmaceutical Packaging, Operation or Quality Department with increasing levels of responsibility or equivalent
Knowledge
Knowledge of Quality MS (Management Systems), Document MS, Learning MS (Trackwise, Master Control, and ComplianceWire respectively); and MS Office Suite; Kronos, Maximo
Solid understanding of all current state, federal and local standards and regulations, e.g., cGMP, OSHA, EEOC, EPA, FDA and DEA
Personnel from outside the pharmaceutical industry or a directly related industry, i.e., medical devices, food, etc., can be considered after critical assessment of their industry related knowledge. Must be able to gain knowledge and expertise in aseptic processing
Skills
&
Abilities
To perform the job successfully, an individual should demonstrate the following competencies:
For internal candidates: meets or exceeds expectations as follows:
Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.
Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.
Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.
Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals. Completes tasks on time or notifies appropriate person with an alternate plan.
Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.
Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs and intended audience; Presents numerical data effectively; Able to read and interpret written information.
Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed
Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures
To perform the job successfully AND progressively achieve, an individual should demonstrate the following competencies:
Design -Generates creative solutions; Translates concepts and information into images; Uses feedback to modify designs; Applies design principles; Demonstrates attention to detail.
Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility/accountability for own actions; Follows through on commitments.
Initiative -Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.
Resilience - Deals effectively with pressure, remains optimistic and persistent even under adversity. Recovers quickly from set backs.
Problem Solving -Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals.
Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.
Adaptability -Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
Physical & Work Requirements
Routine entry into a manufacturing environment that requires garbing in and out of environmentally controlled areas up to ISO Grade 5.
Stand, Walk, Sit, Talk and/or Hear
Occasionally required to reach with hands and arms and stoop, kneel, crouch, or crawl.
Specific vision abilities required by this job include close vision
Frequently working near or exposed to moving mechanical parts
The noise level is moderate
Occasional exposure to fumes, airborne particles, toxic or caustic chemicals
Work environment is a production/manufacturing plant
Disclaimer:
The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
EEO Statement:
We firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.
Auto-ApplyNeuro Sales Representative - Ann Arbor
Ann Arbor, MI job
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
**Job Function:**
Pharmaceutical Sales
**Job Sub** **Function:**
Sales - Neuroscience (Commission)
**Job Category:**
Professional
**All Job Posting Locations:**
Ann Arbor, Michigan, United States
**:**
**Neuro Sales Representative - Ann Arbor**
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************/ .
Johnson & Johnson has entered into an agreement to acquire Intra-Cellular Therapies, Inc, a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders. With a differentiated commercialized therapy and promising clinical-stage pipeline that complements our current areas of focus, this acquisition brings us one step closer to achieving our ambition of becoming the #1 neuroscience company worldwide.
Intra-Cellular Therapies, a Johnson & Johnson company, is on the path to be the #1 leader in neuroscience. With an exceptional suite of products and a commitment to transforming patient lives, we are expanding our CAPLYTA medical team to support our growing impact in psychiatry.
The Neuroscience Sales Representative has overall responsibility for meeting or exceeding sales expectations within their assigned geographies in an ethical and compliant manner. The NSR is responsible for understanding and identifying customer needs, aligning marketing resources and supporting pull-through activities. They are also accountable for embodying and communicating Intra-Cellular's corporate vision of delivering innovative treatments to improve the lives of individuals with neuropsychiatric, neurologic, and other disorders to improve the lives and reduce the burden on patients and caregivers.
The Neuroscience Sales Representative will develop superior product and disease state knowledge that allows them to compliantly engage in in-depth clinical dialogue with healthcare professionals. Additionally, they will have responsibility for the creation of local strategic and tactical plans, differential resource allocation, and accountability for effective application of budget and expense management within their assigned territory.
We are looking for sales professionals who have a passion for patients, tenacity for results, ability to adapt and evolve, entrepreneurial thirst for working in an energizing and winning culture.
**Job Responsibilities:**
+ Following compliance guidelines, drives sales performance to ensure sales forecasts are met or exceeded within assigned territory by calling on predominantly Primary Care HCP offices and select PC targets within both in-person and virtually.
+ Develop superior product and disease state knowledge and effectively educate and engage healthcare professionals in dialogue about clinical evidence, approved indications, and product efficacy/safety profiles to support on-label prescribing for appropriate patients.
+ Effectively uses assigned budgets to achieve territory objectives. Customizes discussions and client interactions based on customer's needs in a compliant and ethical manner.
+ Function independently with sales proficiency to drive sales performance and ensure sales forecasts and assigned budgets meet or exceed therapeutic and territory expectations.
+ Maintains current understanding of local market, practice structures, evolving customers, and key influencers. Routinely shares such information with relevant internal Intra-Cellular stakeholders.
+ Provides input into resource allocation decisions across customers/region. Identifies and selects programs/resources available and appropriate for each customer, practice, and/or system.
+ Provides special education to healthcare providers through appropriate programs that fall within ITCI's ethical guidelines.
+ Works with District Manager and key stakeholders to develop a local business plan that ensures achievement of all business objectives. Capitalizes on formulary approvals and other business opportunities through effective implementation of the strategic plan.
+ Collaborates with other Neuroscience Sales Specialist-II's on common objectives and sharing of best practices.
+ Accountable for providing timely and accurate administrative management of work hours, sales call data, customer objectives, communication responses, synchronization, sample and expense reporting.
+ Expected to meet or exceed all NSR deliverables.
+ Effectively create and build a compliant business plan based on depth and breadth of customer business needs, resources and products.
+ Complete all company and job-related training as assigned within the required timelines.
+ Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
**Job Requirements:**
+ Must have Bachelor's degree from an accredited college or university as well as a valid driver's license and safe driving record.
+ Must have 1+ years of documented success in B2B sales experience required; previous sales experience in pharmaceuticals, biologics, and/or medical device sales preferred
+ Antipsychotic, and/or bi-polar sales experience is a plus.
+ Must have strong desire and passion for improving the lives of patients and their caregivers. Ideal candidate emulates patient-centricity.
+ Must act with high integrity and always in accordance with the Company's Compliance policies and procedures.
+ Must have strong sense of self-motivation, initiative, and entrepreneurial thirst, excellent decision-making judgment, strong teaming/collaboration and cross-functional skills.
+ A proven track record of success in learning and adapting to an evolving environment such as Covid-19 in order to overcome obstacles and challenges.
+ Must have ability to be agile and adapt to the changing telemedicine/virtual environment.
+ Ability to analyze data/metrics to assess progress against objectives as well as diagnose performance issues and identify new opportunities.
+ Must have strong verbal, presentation, and listening skills.
+ Experience establishing new customer relationships and communicating technical information to a diverse customer audience.
+ Work hours may include meetings scheduled outside of normal working hours.
+ Territories may require some overnight travel depending on geography.
+ Some domestic travel to corporate headquarters, training and sales meetings will also be required on a periodic basis.
+ Must be able to perform all essential functions of the position, with or without reasonable accommodation.
\#ITCIBuild2025
Salary range for this position: $79,000 - $130,000
_Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation,_ **_external applicants please contact us via_** **_*******************/contact-us/careers_** **_. internal employees contact AskGS to be directed to your accommodation resource._**
**About Johnson & Johnson**
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************/.
**Required Skills:**
**Preferred Skills:**
Analytical Reasoning, Business Behavior, Clinical Experience, Communication, Cross-Functional Collaboration, Cultural Competence, Customer Centricity, Data Savvy, Developing Partnerships, Execution Focus, Market Knowledge, Neuroscience, Pharmaceutical Industry, Pharmaceutical Sales Marketing, Problem Solving, Report Writing, Sales, Sales Support, Sales Trend Analysis, Strategic Sales Planning
Automation Technician U-05 - 2nd Shift
Rochester, MI job
Use Your Power for Purpose
Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what's possible and taking action.
What You Will Achieve
Working with Pfizer's dynamic engineering team, you will play a critical part in managing the Automation engineering activities involving the install, design, program, maintenance, and repair of Automation systems.
This position maintains and repairs all Automation, Manufacturing, Packaging/Inspection, and Utility systems/equipment with a focus on the maintenance and repair of the control system and associated equipment to ensure operation in compliance with cGMP requirements and the Occupational Health and Safety Act and OSHA standards. Responsible to troubleshooting, diagnostics, disassembly, assembly, repair, identifying and replacing parts and a proactive maintenance of systems and electrical equipment in a cost-effective manner.
You are recognized as a subject matter expert with specialized knowledge and skills in procedures, techniques, tools, materials and equipment. You will be entrusted with adapting standard methods and procedures by applying your knowledge, prior work experience and requirements. You will train others and reinforce behaviors that will help us achieve our goal of providing the best healthcare to our patients.
It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Preventive Maintenance:
Performs Preventive and Predictive Maintenance of electrical and controls systems, following the established guidelines for the CMMS system, operational procedures, site and Manufacturer recommended maintenance practices.
Reports opportunities identified during Preventive Maintenance execution.
Review and provides recommendations for Preventive Maintenance task improvements.
Follow the maintenance plan and alerts when there might be a risk of not complying with the schedule.
Generates Maintenance work order to report and coordinate repairs for task out of the scope of the Preventive Maintenance.
Installs, repairs, inspects, test, replace and maintains control systems/components.
Equipment Troubleshooting:
Manages all functions of the Qualified Building Management System and Building Management System (QBMS/BMS) and is responsible for wiring diagrams, backups, and Automation reports (i.e., alarms, trending, etc).
Maintaining all control systems (programmable logic controllers (PLC).
Implement program (i.e., PLC, HMI, SCADA, BMS/QBMS, Historian, Robots, SQL, etc.) modifications.
Automation system software installation and configuration.
Install, maintain, and inspect Automation control system, workstation (HMI/OIT), VFDs, devices.
Install, maintain, inspect and replace electrical and communication (ethernet) wiring.
Interface daily with computers, performing data entry and data (i.e., trend report, alarm reports) retrieval.
Install, replace and troubleshooting variable frequency drives, encoders, motor, computerized vision system.
Responsible for Automation Disaster Recovery task (system and data backups, restores, archives, migration and export).
Responsible for the Automation SDLC documentation (i.e., URS, SIA, DDS, FDS, SCR, Backup Forms) reports.
Responsible for the Logical Security task (User Account Management) for the Automation System.
Monitor, investigate, communicate, document and address Automation Systems alarms in a daily basis.
Installs, inspects, troubleshoots, repairs, and maintains Automation system/devices.
Develop solutions to routine problems following established Pfizer policies and procedures.
Utilizes tools, equipment, ladders, lifts, etc., in safe manner per plant safety procedures. Maintains a clean and safe jobsite at all times.
Participates in safety training programs.
Projects:
Provides support for Capital projects which includes but not limited to Installation, commissioning, and qualification, (I/O, alarm, drawing, startup, and shutdown sequence, verification, etc.) and/or functional testing.
Documentation Responsibilities:
Follows Good Documentation Practices per compliance requirements (i.e. 21 CFR Part 11, Data Integrity).
Completes documentation required for maintenance work and logbooks.
Training, SOP's and GMP:
Reads and follows SOPs, Job Aids, PMs, work orders and other required documents and procedures.
Must be able to complete sterile garb training and work aseptically in manufacturing areas.
Complete trainings in PLS and assists in training of new colleagues as required.
Recommends changes to Maintenance tasks and/or SOP's.
EHS:
Follows EHS procedures, recommended practices, job safety analysis and safe work permit.
Report any abnormal situation that can impact environment, health and or safety of the colleague.
General / Other Responsibilities:
Assists other trades when necessary and or perform other duties as instructed.
Ability to learn how to operate Power trucks / Power lift and elevated platforms.
Housekeeping - Responsible for keeping assigned areas, as well as general areas clean and organized.
Escort Contractors.
May perform any other Engineering or Maintenance duty as requested by management.
Here Is What You Need(Minimum Requirements)
Applicant must have a high school diploma and/or general education degree (GED).
3+ years of experience of Industrial PLC, Controls or automation maintenance, repair and troubleshooting experience.
Ability and experience reading, modifying, troubleshooting Programmable Logic Controllers, HMIs and PLCs. Knowledge of programming languages (Ladder, Sequential Function Chart, Structural Test, Function block).
Demonstrated aptitude in electrical and instrumentation skills.
Knowledge of industry practices and standards.
Knowledge of basic mathematics.
Well-developed time management and problem-solving skills.
Excellent communication skills and strong work ethic.
OEM trained and certified in industrial automation systems (Eg: Rockwell (PLC/HMI/SCADA/BMS), Fanuc, Network Architecture, Systech vision systems).
Bonus Points If You Have (Preferred Requirements)
Licensed electrician from the State of Michigan (i.e. Journeyman or higher).
OEM trained and certified in industrial electrical systems (NFPA-70E).
GMP Maintenance experience in a pharmaceutical manufacturing.
PHYSICAL/MENTAL REQUIREMENTS
Physical/Mental Requirements
This position is in a Penicillin Facility. The candidate must NOT be allergic to Penicillin.
This position requires the ability to:
Make precisely coordinated movements.
Lift, push, pull, or carry objects.
Work at heights on ladders.
Lift up to 40 lbs.
Use of PPE (including but not limited to: eye protection, hearing protection, “Arc Flash” protection and foot safety wear).
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Non-standard work schedule, travel or environment requirements
This is a 2nd shift position with core hours from 3:00pm to 11:30 pm Monday through Friday with overtime required as needed.
The candidate will be required to work off-shift and weekends to support production schedule as needed.
This is a union position; membership in union is required after 30 days.
At different times of the year, this position will work long hours for scheduled manufacturing shutdown periods.
Must be able to complete sterile garb training and work aseptically in manufacturing areas.
Work Location Assignment: On Premise.
Hourly Rate: $48.12
The salary for this position ranges from $0.00 to $0.00 per hour. In addition, this position offers eligibility for overtime, weekend, holiday and other pay premiums depending on the work schedule and the Company's policies. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided applies only to the United States - Michigan - Rochester location.
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
Pfizer endeavors to make ********************** accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.
Engineering
Auto-ApplyScientist, Lab Tech Services - Microbiology
Rochester, MI job
Why Us?
We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
Summary
The Senior Scientist, Laboratory Technical Services is primarily responsible for supporting the microbial testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. Has expert proficiency and takes lead role in conducting all types of microbial analyses (including the most complex analyses) using all equipment. This position will have a role supporting pending ANDA submissions, product launches, complex investigations, onboarding of new equipment and technology, develops and executes training activities, and method lifecycle activities to achieve company goals and initiatives, and is considered an SME for these areas. Write and review SOPs, test methods, validation protocols and validation reports. The Scientist also provides mentoring to analysts.
Job Description
The Scientist, Laboratory Technical Services is primarily responsible for supporting the microbial testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. Has expert proficiency in conducting all types of microbial testing and analyses (including the most complex analyses). This position will have a significant role supporting improvements, training creation and executions, testing, and equipment onboarding. Write and review SOPs, test methods, validation protocols and reports. The Scientist also provides mentoring to Microbiologists.
Support microbial testing for commercial and pre-commercial products
Support method development, validation, and transfer activities
Perform complex microbial analyses using lab equipment
Investigate complex product issues and support product development
Manage method lifecycle activities
Write and review SOPs, test methods, and validation documents
Serve as a subject matter expert (SME) in microbial testing
Mentor Scientists and Microbiologists
Key Responsibilities
Perform routine microbiological testing on raw materials, in-process samples, and finished products
Conduct or understanding of sterility, endotoxin, bioburden, microbial limit, and microbial identification tests
Analyze environmental monitoring samples from cleanrooms and production areas
Support Validation of microbial methods for product and raw material testing
Prepare protocols, reports, and test methods
Conduct testing to support development and stability studies
Present and review data with project teams
Review lab documentation and supplier technical documents
Use lab software and detect abnormalities during testing
Provide general lab support and maintain equipment
Troubleshoot instruments and perform follow-up analyses
Report and investigate out-of-specification results
Write and review SOPs and investigation reports that support root cause analysis
Recommend corrective and preventive actions (CAPA)
Support training of microbiologists and improve training process records
Maintain accurate records in accordance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP)
Ensure compliance with FDA and other regulatory standards
Follow safety procedures and handle hazardous materials properly
Uses laboratory software for analyses
Is alert to and detects abnormalities during performances of tests and reviews
65%
Lab Equipment
Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, and housekeeping
Troubleshoots instrumentation and performs subsequent analyses
20%
Investigations
Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action
Participates in root cause identification of complex laboratory investigations
Writes, edits, and reviews SOPs and laboratory investigations
10%
Training
Trains microbiologists
Continuously updates knowledge with respect to the latest technologies related to Microbiology
Maintains assigned training records current and in-compliance
Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, methodologies and procedures
5%
Compliance
Identifies need for SOPs and writes or revises, as appropriate
Performs work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting. Works in compliance with cGMP/cGLP regulations
Documents data generated in notebooks/worksheets/LIMS in compliance with SOPs
Takes active role in auditing laboratory logbooks/documentation to ensure compliance
Follows internal processes related to controlled substances
continuous
Safety
Follows EH&S procedures to ensure a safe work environment
Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS
continuous
Total
100%
Qualifications
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
Bachelor of Science Degree in Microbiology or related field with 6 years' relevant microbiological laboratory experience OR
Master's Degree in above disciplines with 4 years' relevant analytical lab experience OR
PhD in above disciplines with some relevant laboratory experience preferred
Knowledge
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
Has expanded knowledge of Microbial Testing such as bacterial endotoxin, sterility, microbial and visual examination, microbial identification, etc.
Full proficiency with various laboratory techniques/instruments: microplate readers, isolator technology, microbial identification systems, etc.
Thorough knowledge of applicable safety and standards guidelines, such as FDA, ICH, SOP, cGMP, GLP, DEA regulations and/or MSDS
Has demonstrated competence in conducting microbial testing
Strong knowledge of aseptic technique and contamination control
Competency in Microsoft Office Suite
Skills
&
Abilities
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing
etc.
Ability to critically review and analyze data, interpret information, and draw conclusions from relevant or missing information
Ability to display and analyze data in a logical manner
Strong verbal and written communication skills as well as good computer skills
Strong attention to details and accurate record keeping
Establish and maintain cooperative working relationships with others
Solid organizational skills
Ability to coach and mentor junior staff while developing their laboratory skills and technical capabilities
Ability to take initiative, set priorities and follow through on assignments
Physical Requirements
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals
Must occasionally lift and/or move up to 15-25 lbs.
Ability to wear personal protective equipment, including respirators, gloves, etc.
Specific visions abilities are required by this job include close vision and color vision
Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods
Disclaimer:
The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
EEO Statement:
We firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.
Auto-ApplyManager/TL Quality Control
Rochester, MI job
Use Your Power for Purpose
This position will oversee the Quality Control Laboratory in Rochester, MI. The Rochester Quality Control Laboratory performs: Assay, Viscosity, Breakloose & Extrusion, Sterility, Gas chromatography, pH, LOD, Bacterial Endotoxin, Karl Fischer, and multiple other analytical technologies used to determine quality attributes for Rochester manufactured Drug Products.
The selected candidate will lead the laboratory to meet defined quality standards and QO objectives. Ensures cost effective activities/programs are implemented in compliance with regulatory standards, company policies, practices, and processes. Fosters teamwork and colleague development, as well as change management, within the laboratory and department. Provides guidance and coaching to QO colleagues and provides direction/approval of activities and decisions. Cultivates and reinforces appropriate group values, norms, and behaviors. Provides oversight to individuals and team on personal development, performance, and quality related issues. Writes and delivers performance reviews and oversees colleague development. Provides oversight of department ensuring proper use of assets, budget, and personnel.
What you Will Achieve
• Review and approve cGMP documentation to assure compliance with regulatory requirements.
• Assess deviation impacts and resolve to prevent future occurrences.
• Review and approve cGMP Changes in accordance with regulatory requirements.
• Review and approve training to assure cGMP requirements are met.
• Manage resources (people and assets) to meet work team goals.
• Support a continuous improvement culture where individuals can thrive in change.
• Thoroughly evaluate lab investigations, deviations, and associated corrective/preventive actions to ensure they are handled appropriately and documented effectively as they relate to the testing of raw materials, in-process samples, and final products.
• Assures adherence to data integrity initiatives.
• As a Subject Matter Expert (SME), represents the lab unit or the entire lab organization on high complexity projects and project teams both within and outside of QO.
• Supports and may lead implementation of various elements of IMEx.
Here Is What You Need
(Minimum Requirements)
Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience
Previous experience with leading colleagues and/or projects is required.
The candidate must have excellent verbal and written communication skills, with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups.
The candidate must have demonstrated proficiency in organizational and project management skills and must be able to balance multiple priorities.
Bonus Points If You Have
(Preferred Requirements)
The candidate should have experience in multiple of the following areas: cGMP, Regulatory, deviation investigations, drug product lot release, analytical method transfer/validation, process validation, laboratory testing, and laboratory investigations.
PHYSICAL/MENTAL REQUIREMENTS
Laboratory and office work require walking, standing, and sitting throughout a shift. The job has minimal lifting but may have extensive sitting and walking time. The ability to concentrate for long periods of time is necessary.
This is a penicillin manufacturing facility. All candidates applying must NOT be allergic to penicillin.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Non- Standard work schedule at times maybe required to support product release, including weekend, second shift, night shift work / call for process decisions.
Minimal travel for training/seminars.
Relocation support available
Work Location Assignment: On Premise
The annual base salary for this position ranges from $102,900.00 to $171,500.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
Pfizer endeavors to make ********************** accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.
Quality Assurance and Control
Auto-ApplyEntry Level Phlebotomist/Medical Screener - Immediate Benefits
Ypsilanti, MI job
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers.
About the role:
Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a plasma donor screener and perform phlebotomy to support plasma center operations.
How you will contribute:
· You will answer phones, and greet and focus on our donors, while ensuring the safety of donors and our team.
· You will screen new and repeat donors and take and record donor vital signs and finger stick results.
· You will use our Donor Information System, prepare donor charts, maintain accurate records, and coordinate donor compensation.
· You will help identify operational opportunities for continuous improvement and initiate changes to center processes using company approved procedures.
· You will be there for our donors, which includes working a variety of shifts, Saturdays and Sundays, and holidays.
What you bring to Takeda:
· High school diploma or equivalent
· Ability to walk and/or stand for the entire work shift
· Will work evenings, weekends, and holidays
· Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees
· Ability to lift to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs.
· Fine motor coordination, depth perception, and ability to hear equipment from a distance
· Because of potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear
· 1 or more years minimum experience working in a customer or patient facing role is helpful
What Takeda can offer you:
Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include retirement benefits, medical/dental, family leave, disability insurance and more, all in a fast-paced, friendly environment.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.
BioLife Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - MI - Ypsilanti
U.S. Starting Hourly Wage:
$17.00
The starting hourly wage reflects the actual starting rate for this position. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsUSA - MI - YpsilantiWorker TypeEmployeeWorker Sub-TypeRegularTime TypePart time
Job Exempt
No
Auto-ApplyScientist, Lab Technical Services
Rochester, MI job
Why Us?
We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
Summary
The Senior Scientist, Laboratory Technical Services is primarily responsible for supporting the analytical testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. Has expert proficiency and takes lead role in conducting all types of physical & chemical analyses (including the most complex analyses) using all equipment. This position will have a significant role supporting pending ANDA submissions, product launches, complex product investigations, product development, and method lifecycle activities to achieve company goals and initiatives, and is considered an SME for these areas. Write and review SOPs, test methods, validation protocols and validation reports. The Senior Scientist also provides mentoring to Scientists and Chemists.
Job Description
Key Accountabilities
- key outcomes/deliverables, the major responsibilities, and % of time
Accountability
Responsibilities
% of Time
Analysis & Testing
Validates analytical methods for Finished Product and Raw Material release and stability testing
Evaluates, troubleshoots/improves existing analytical methods when necessary
Prepares method validation protocols, reports, and analytical test methods
Performs testing to support process and formulation development (e.g. excipient compatibility, solubility, dissolution studies, stability/impurity assessment)
Performs work to support project as assigned with little oversight
Presents analytical data to project team for review and discussion
Reviews and approves laboratory test data and documentation (e.g. notebooks, raw data and technical documentation, test method, validation protocol, or validation report) for completeness and compliance when necessary
Reviews and evaluates drug substance supplier's technical documents to ensure internal test requirements are adequate
Uses laboratory software for analyses
Is alert to and detects abnormalities during performances of tests and reviews
65%
Lab Equipment
Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping
Cleans lab working surfaces and dispose of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals
Troubleshoots instrumentation and performs subsequent analyses
20%
Investigations
Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action related to LTS activities
Participates in root cause identification of complex laboratory investigations
Writes, edits, and reviews SOPs and laboratory investigations
10%
Training
Trains junior Scientists/Chemists on analytical techniques
Continuously updates knowledge with respect to the latest technologies related to analytical science
Maintains assigned training records current and in-compliance
Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, and chemical theories, methodologies and procedures
5%
Compliance
Identifies need for SOPs and writes or revises, as appropriate
Performs work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting. Works in compliance with cGMP/cGLP regulations
Documents data generated in notebooks/worksheets/LIMS in compliance with SOPs
Takes active role in auditing laboratory logbooks/documentation to ensure compliance
Follows internal processes related to controlled substances
continuous
Safety
Follows EH&S procedures to ensure a safe work environment
Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS
continuous
Total
100%
Qualifications
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
Bachelor of Science Degree in chemistry, chemical engineering or related field with 6 years' relevant analytical laboratory experience OR
Master's Degree in above disciplines with 4 years' relevant analytical lab experience OR
PhD in above disciplines with some relevant analytical laboratory experience preferred
Knowledge
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
Has strong knowledge of laboratory software and has expanded knowledge of chromatographic software (e.g. Waters Empower, Agilent ChemStation and Sotax WinSotax), using custom fields, custom calculations and custom reports
Full proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.
Thorough knowledge of applicable safety and standards guidelines, such as FDA, ICH, SOP, cGMP, GLP, DEA regulations and/or MSDS
Has demonstrated competence in conducting chemical analyses
Strong knowledge of wet chemistry techniques
Competency in Microsoft Office Suite
Skills
&
Abilities
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing
etc.
Ability to critically review and analyze data, interpret information, and draw conclusions from relevant or missing information
Ability to display and analyze data in a logical manner
Strong verbal and written communication skills as well as good computer skills
Strong attention to details and accurate record keeping
Establish and maintain cooperative working relationships with others
Solid organizational skills
Ability to coach less senior staff and develop laboratory skills and ability
Ability to take initiative, set priorities and follow through on assignments
Physical Requirements
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals
Must occasionally lift and/or move up to 15-25 lbs.
Ability to wear personal protective equipment, including respirators, gloves, etc.
Specific visions abilities are required by this job include close vision and color vision
Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods
Disclaimer:
The above statements are intended to describe the general nature and level of work performed by employees assigned to
EEO Statement:
We firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.
Auto-ApplyOncology Sales Specialist - Southern Michigan Overlay- Johnson & Johnson Innovative Medicine
Ann Arbor, MI job
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
**Job Function:**
Pharmaceutical Sales
**Job Sub** **Function:**
Sales - Oncology/Hematology (Commission)
**Job Category:**
Professional
**All Job Posting Locations:**
Ann Arbor, Michigan, United States, Detroit, Michigan, United States
**Job Description:**
We are searching for the best talent for an Oncology Sales Specialist to cover the Southern Michigan Overlay territory.
**About Oncology**
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine
The Oncology Sales Specialist (OS) is a Field Based role reporting to a District Manager. As the OS you will:
+ Fulfill sales strategies by promoting current and potential new oncology therapeutics within approved specialties and accounts.
+ Demonstrate a working knowledge of the products' clinical efficacy and safety, articulate a value proposition for the customer, provide clinical information as needed, and achieve brand sales objectives.
+ Conduct business analysis, actively prospect for new business within geography, align with sales and marketing strategies, develop account plans with District Manager and internal partners.
+ Develop customer specific pre- and post-call plans that include objectives, probes and supporting approved materials.
+ Appropriately utilize all company approved marketing tools and resources, including digital presentations, use selling skills framework to advance in the selling cycle (i.e., another appointment, in-service, patient identification, etc.).
+ Request, organize and attend relevant oncology conferences which may occur on weekends.
+ Effectively and compliantly discuss access and reimbursement options with customers to improve sales opportunities utilizing approved resources and messaging.
\#eradicatecancer
**Qualifications:**
**Required:**
+ A minimum of a bachelor's degree
+ Valid driver's license and the ability to travel as necessary, including overnights and/or weekends
+ A minimum of two (2) years of relevant work experience in healthcare sales/account management, or business to business sales, or recently transitioned from Active-Duty Military
+ The ability to travel up to 50%, which may include overnight / weekend travel
+ Residing in the geography or willing to relocate
**Preferred:** ** **
+ Specialty sales experience and an understanding of Solid Tumor Oncology
+ A proven track record of success and ability to influence and impact key stakeholders in a dynamic competitive selling environment
+ Experience in hospital and large account sales with a documented history of successful sales performance in a complex and competitive environment
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.
At Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time.
Here's What You Can Expect
+ Application review: We'll carefully review your CV to see how your skills and experience align with the role.
+ Getting to know you: If there's a good match, you'll be invited to complete a short-recorded video interview, giving you the chance to share more about yourself. If successful, a recruiter will also reach out by phone to walk you through the process and answer any questions.
+ Interviews with the team: If you move forward, you'll meet with the hiring manager (and possibly others on the team) in one or two interview rounds, depending on the role.
+ Staying informed: We know waiting can be hard, so our recruitment team will keep you updated and make sure you know what to expect at each step.
+ Final steps: For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these.
At the end of the process, we'll also invite you to share feedback in a short survey - your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We're excited to learn more about you and wish you the best of luck in the process! #RPONA
**Required Skills:**
**Preferred Skills:**
Clinical Experience, Communication, Cross-Functional Collaboration, Customer Centricity, Customer Retentions, Data Savvy, Developing Partnerships, Hematology, Market Knowledge, Oncology, Performance Measurement, Pharmaceutical Industry, Pharmaceutical Sales Marketing, Problem Solving, Product Knowledge, Relationship Building, Sales, Sales Projections, Sales Trend Analysis, Strategic Sales Planning
Associate Director, Thought Leader Liaison - Neuroscience - Great Lakes
Ann Arbor, MI job
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Medical Affairs Group
Job Sub Function:
Professional Medical Education
Job Category:
Professional
All Job Posting Locations:
Ann Arbor, Michigan, United States, Fort Wayne, Indiana, United States, Grand Rapids, Michigan, United States, Indiana (Any City), Lansing, Michigan, United States, Michigan (Any City), Saginaw, Michigan, United States
:
We are recruiting for an Associate Director, Thought Leader Liaison - Neuroscience to support the Great Lakes (MI, IN) region. This is a field-based position, with preference for the candidate to be in a major metropolitan market with easy access to a national airport.
This is a field based role available in Michigan and Indiana. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************/.
Johnson & Johnson has entered into an agreement to acquire Intra-Cellular Therapies, Inc, a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders. With a differentiated commercialized therapy and promising clinical-stage pipeline that complements our current areas of focus, this acquisition brings us one step closer to achieving our ambition of becoming the #1 neuroscience company worldwide.
The Associate Director, Thought Leader Liaison -Neuroscience, will be responsible for leading the CAPLYTA Key Opinion Leader (KOL) engagement strategy, as well as contributing significantly to the overall KOL strategy across the Neuroscience franchise in close collaboration with the brand team. This territory includes MI, IN.
Job Responsibilities
* Lead the development and execution of Regional KOL engagement strategy, marketing education strategy and faculty development. This includes oversight of regional peer to peer marketing plans, health care compliance training for faculty, and other related activities as needed.
* Serve as a key member of the CAPLYTA Brand team by providing local market insights and feedback to craft future strategies for the Neuroscience franchise in close collaboration with sales leaders, key business partners, and medical teams to elevate brand advocacy.
* Build trusting relationships with academic and community KOLs, and other key partners to achieve above-brand priorities.
* Maintain pulse on regional trends and closely coordinate regional marketing education and engagement plans with cross functional partners to ensure heightened KOL and customer engagement strategies that are fully aligned to the Brand strategic imperatives.
* Partner with coordinated analytics team to better understand regional variations in treatment patterns to advise peer to peer and insight program placement.
* Attend conferences and serve as onsite host for product theatres
* Facilitate, participate, and attend advisory boards where appropriate
* Coordinate executive engagements with KOLs and commercial leadership
* Closely supervise the regional marketing budget and provide continuous feedback on business planning.
* Assist in crafting future innovative educational platforms including national and regional recommendations to tailor our education to local needs and creating innovative solutions in further engaging KOL's at all regional and national medical congresses.
* Leadership of the overall neuroscience strategy inclusive of mapping, framework development, innovative engagement planning for current brands and future launches, inclusive of marketing operations for KOL strategy and planning including agency management, champion materials through CAC, Totality, MRC.
Job Requirements
* BA/BS Degree Required; advanced degree preferred.
* Minimum 6 years of experience in marketing, key account management, medical, sales leadership, sales training, or field sales engaging with KOLs/Influential HCPs and professional healthcare organizations.
* Deep understanding and experience working cross functionally with various key internal & external partners with a strong ability to innovate, collaborate and deliver results with desired outcomes.
* Demonstrated understanding of key industry trends and ability to develop strategies to stay ahead of the competition and improve patient outcomes.
* Demonstrated ability to build and manage relevant and lasting customer relationships with strong focus on patient impact and outstanding customer centricity.
* Travel can be up to 65%; this includes internal meetings, advisory boards, medical meetings, congresses, and select program attendance.
* A Valid Driver's license issued in the United States.
Preferred:
* Minimum 5 years of experience in neuroscience.
* Previous cross-functional industry experience in pharma or biotech engaging with KOLs and professional healthcare associations is preferred.
* Deep medical/scientific knowledge/experience with a firm understanding of the psychiatry marketplace is preferred.
* Experience leading through change and transformation, product launches, and exceptional communication and leadership skills is preferred.
* Complete all company and job-related training as assigned within the required timelines.
* Must be able to perform all essential functions of the position, with or without reasonable accommodation.
* Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice
#NeuroTLLBuild
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Brand Marketing, Channel Partner Enablement, Digital Strategy, Global Market, Learning Materials Development, Medical Affairs, Medical Communications, Mentorship, Organizing, Process Improvements, Program Management, Sales Enablement, Sales Presentations, Strategic Sales Planning, Strategic Thinking, Technical Credibility, Training People
The anticipated base pay range for this position is :
$137,000.00 - $235,750.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
* Vacation -120 hours per calendar year
* Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
* Holiday pay, including Floating Holidays -13 days per calendar year
* Work, Personal and Family Time - up to 40 hours per calendar year
* Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
* Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
* Caregiver Leave - 80 hours in a 52-week rolling period10 days
* Volunteer Leave - 32 hours per calendar year
* Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - *********************************************
Auto-ApplySterile Fill Production Machine Operator (Midnights)
Rochester, MI job
Why Us?
We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
Summary
Why Endo?
We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
At Endo, we are building a diverse, equitable and inclusive workplace, and we are looking for talented individuals to join our team.
In accordance with Current Good Manufacturing Practices, Standard Operating Procedures (written and/or oral) instructions and Safety Regulations are responsible for the continuity of complex operations required to maintain production.
Job Description
Key Accountabilities
- key outcomes/deliverables, the major responsibilities, and % of time
Accountability
Responsibilities
% of Time
Operational
Sets-up, checks, adjusts and runs production equipment as required by product and size change over. This requires the PMO to bend, lift, use both hands and have correct 20/20 vision
Communicates effectively and on a timely basis to fill and seal operators
Coordinates with Area Supervisors to ensure an efficient filling operation
Communicates with Supervisor in a proactive manner with respect to line operating conditions, product quality status, and potential improvements
Cleans lubricates, starts, stops and services equipment necessary to promote and maintain a smooth & efficient flow of production
When necessary, performs required environmental and personnel monitoring sampling and recording
Determines and verifies that correct and adequate labels, materials and supplies have been provided to meet production schedules
Maintains a continuous supply of materials to production lines
Notifies Area Supervisor of processes or equipment not in a state of regulatory compliance when discovered
70%
Documentation
Documents all line clearance forms and other documentation forms necessary for the processing of each batch
Records downtime, production output and other manufacturing documents as assigned
10%
Compliance
Maintains eligibility for core qualification
10%
Testing
Integrity tests sterilizing filters
10%
Other
Performs other duties as assigned by Area Supervisor
Continuous
Total
100%
Qualifications
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
High School Diploma, GED or equivalent
Successful completion of in-house training programs (includes Upgrader Exam)
Knowledge
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
Arithmetic Aptitude preferred
Pressure and Temperature Aptitude preferred
Skills
&
Abilities
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing
etc.
Mechanical Aptitude preferred
Hand Tools and Measuring Instruments Aptitude preferred
Physical Requirements
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
Required to reach with hands and arms and frequently required to use hands to finger, handle or feel
Occasionally lift and/or move up to 50 pounds
Specific vision abilities required by this job include close vision
Frequently exposed to moving mechanical parts
Frequently exposed to toxic or caustic chemicals
The noise level is moderate
Work environment is a production/manufacturing environment
Commitment to Diversity, Equity, and Inclusion:
At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person's unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.
EEO Statement:
At Endo we firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.
EEO Statement:
We firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.
Auto-Apply