Job Title: Strategic Account Manager- Vaccines
About the Job
Join the team protecting half a billion lives every year with next-gen science, mRNA innovation, and AI-driven breakthroughs. In Vaccines, you'll help advance prevention on a global scale - and shape the future of immunization.
The Strategic Account Management organization is a highly skilled forward-thinking sales team serving our largest and most complex customers, while also managing our highest valued vaccine contracts. The customers we call on primarily include Health Systems, IHNs, Medical Groups, PBGs, FQHCs and state Awardees.
About Sanofi:
We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.
Main Responsibilities:
Assume the leadership role within assigned accounts, providing overall account leadership to cross-functional internal and external team members as needed. In this capacity, the SAM will assume responsibility for assigned strategic customers and manage each as a business partnership on behalf of Sanofi. Additionally, the SAM will bear full responsibility for building a strategic account plan for assigned accounts, as well as organizing and deploying the appropriate resources within Sanofi to drive value co-creation with customers and meet/exceed Sanofi's revenue targets.
Effectively manage and grow a network of trust-based relationships with external stakeholders to generate revenue through genuine partnerships within Sanofi's largest and most complex customers. The SAM will develop a deep understanding of the customer's business which includes their pressures and drivers, priorities, as well as their related challenges and opportunities. They will maintain working knowledge of the customer's business model, strategic goals and objectives, and their position within the healthcare environment including value-based health care, their competitors, and financial levers.
Identify and qualify high value opportunities within their accounts by working directly with the customer to develop and drive growth strategies, team-to-team alignment, and executive relationships together with internal cross-functional team members. Accordingly, the SAM will conduct business coaching and strategy session with their account teams to facilitate the co-creation of customer value and ensure ongoing internal alignment and account growth. The SAM will function as the central focal point for communications regarding account planning, strategy, collaboration, resource allocation and customer engagement.
About You
Basic Qualifications
Minimum required skills & experience:
Bachelor's degree required
5+ years of field sales or account management experience
Internal candidates with a consistent history of performance along with demonstrated capabilities or competencies may be considered with less experience.
Broad understanding of health system business, decision making processes & market trends with a proven track record of accessing C-suite to D-suite decision makers
Proven ability to translate health system market knowledge and develop strategic plans with internal stakeholders
The ability to execute tactical initiatives, provide ongoing feedback, and prioritize multiple projects.
Broad field sales experience with demonstrated success working with P&T committees, decision makers & influencers in Hospitals, Health Systems, IHNs and other large-organized customers
Possesses strong business acumen and strategic thinking skills
Self-directed and organized with excellent execution and planning skills
Ability to adapt and change in a shifting environment
Excellent communication skills both written and oral
Must possess valid driver's license, be eligible for insurance coverage and must be able to safely operate a vehicle
Minimum preferred skills & experience:
MBA or other advanced degree
Strong data analytics
Experience working in Market Access, Pricing, Contracting or Finance
Proficient with MS Office and customer management databases
Experience leading teams with demonstrated impact & influence with key internal stakeholders
Travel:
Ability to travel up to 75% of the time to customers, conventions, training, and other internal meetings.
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
This position is eligible for a company car through the Company's FLEET program.
Candidates must complete all fleet safety training and must maintain an acceptable driving record regarding accidents and incidents.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
#GD-SP
#LI-SP
#LI-Remote
#vhd
Pursue
progress
, discover
extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
North America Applicants Only
The salary range for this position is:
$122,250.00 - $176,583.33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
$45k-77k yearly est. Auto-Apply 60d+ ago
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Therapeutic Specialist Tzield, Raleigh, NC
Sanofi Us 4.3
Sanofi Us job in Raleigh, NC
Job title:
Therapeutic Specialist Tzield, Raleigh, NC
About the Job
Therapeutic Specialist, Tzield are part of the National Tzield Sales Team and play a pivotal role in bringing a paradigm-shifting Type 1 Diabetes product to market. Therapeutic Specialists leverage their deep sales experience and expertise to accelerate Tzield adoption across providers and accounts and collaborate closely with all respective cross-functional partners. This role will develop territory-specific sales strategies, educate endocrinology and primary care providers on both Tzield and screening, and build a robust Tzield customer base.
We are an innovative global healthcare company with a focus on immunology that extends to innovation in diabetes and transplant medicine. Across different countries, our talented teams are determined to deliver a best-in-class customer experience using the best of digital, artificial intelligence and personal know-how. With a focus on immunology that extends to innovation in diabetes and transplant medicines, we pursue progress to make a real impact on millions of patients around the world.
Join the team transforming how healthcare is delivered for chronic and specialty conditions worldwide. In General Medicines, you'll help drive meaningful outcomes in diabetes, transplant, and immunology - with the scale and urgency patients deserve.
About Sanofi:
We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.
Main Responsibilities
Brand Awareness & Intent to Treat with Endos.
Build belief in Tzield mechanistic rationale and clinical narrative (e.g., MOA involving beta cell preservation, approved indication, efficacy / safety profile).
Develop in-depth knowledge and understanding of key accounts across territory, including barriers to Tzield use.
Contribute to priority account strategy development lead by SAMs and own execution to engage endocrinology and primary care providers on Tzield use.
For non-priority Endo in territories, own the development and execution of growth-oriented account & business plans (e.g., account mapping, influence mapping, etc.).
Identify account champions / KOLs and engage them as necessary and appropriate to communicate with peers and patients about Tzield.
Screening Awareness & Development of T1D Ecosystem.
Build belief in T1D early detection and importance of screening for T1D in asymptomatic, undiagnosed, early detection population.
Conduct strategic planning at territory level to understand and contribute to development of broader T1D ecosystem in order to prioritize time, engagement, and education strategy.
Contribute to screening strategy development and own execution to engage PCP / Ped on early detection & screening.
Collaborate with stakeholders to identify and educate on importance of urgent referrals for identified patients within narrow treatment window.
Educate relevant stakeholders on at-risk populations, screening / monitoring best practices, and the value of early detection (e.g., DKA avoidance).
Additional Responsibilities
Collaborate closely with cross-functional Sanofi teams to support customers.
Attending local, regional, and national meetings as directed.
Maintaining strict adherence to all legal, regulatory, ethical, administrative, and financial duties.
Achieving and exceeding assigned monthly, quarterly, and annual sales quotas.
About You
Qualifications
B.A. / B.S. degree required.
3+ years of pharmaceutical, biotech or medical device sales experience.
Account Management sales and / or rare specialty product experience.
Demonstrated ability to understand and use data to drive improved business management and oversight of the sales within customer territories.
Proven results of increasing educational awareness, provider adoption and customer engagement.
Experience successfully launching products in the field.
Experience collaborating and working in a matrix environment across multiple different sales, medical and support functions.
Strong business acumen and solution-oriented mind-set
Ability to strategically plan and execute work.
Robust communication skills and ability to engage in two-way stakeholder dialogue.
High accountability for all feedback, coaching, and results
Valid driver's license.
Ability to travel up to 80% of the time to customers, conventions, training, and other internal meetings.
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
Help shape the future of care for chronic and complex conditions like aT1D, Type 2 diabetes, transplant, and cardiovascular disease.
Be part of a simpler, digital- and AI-powered business that's rethinking how we work and engage with the world.
Drive meaningful impact at global scale: our medicines reach more than 100 million people each year.
Contribute to innovations that improve outcomes, relieve pressure on healthcare systems, and expand access worldwide.
This position is eligible for a company car through the Company's FLEET program. Candidates must complete all fleet safety training and must maintain an acceptable driving record regarding accidents and incidents.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
#GD-SA
#LI-SA
#LI-Remote
#vhd
Pursue
progress
, discover
extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
North America Applicants Only
The salary range for this position is:
$125,250.00 - $180,916.66
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
$25k-33k yearly est. Auto-Apply 21d ago
Sr. Quality Analyst
Endo Pharmaceuticals Inc. 4.7
Raleigh, NC job
Why Us?
At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day.
Summary
The Sr. Quality Analyst serves as the primary for customer inquiries, gap assessments, customer audit coordination, and inspection readiness. Additionally, the Sr. Quality Analyst serves as a primary back up for release work for finished product, batch record review, and label preparation.
Job Description
ESSENTIAL FUNCTIONS:
Utilize inventory management systems (BPCS) and other associated quality systems to ensure proper release of product for the Raleigh manufacturing site.
Primary point of contact for the Raleigh site for customer inquiries and required documentation for GMP customer requests.
Schedule customer audits and coordinate all associated activities, including but not limited to tracking responses and action items to completion.
Maintenance of the Site Inspection Readiness Program
ADDITIONAL FUNCTIONS:
Act as a primary back-up for batch record reviews. This includes providing timely and thorough audits of all product batch records to ensure site compliance with cGMP regulations, picking up all batch records to be audited from the plant and returning all audited records to the plant (minimum is once daily but could require multiple trips), and providing batch record training as needed for all production employees and potential new QA Analysts.
Reviews and approves Certificate of Analysis (CoA) documents.
Performs administrative activities for the Quality department. This includes ordering supplies and other materials for both, QA and QC as well as filing.
Provides support to investigations, both exceptions and OOSs, to support product disposition.
Programs label changes and add new codes to the labeling computer
Makes, proofs, and records all finished lot labels to meet the production schedule and as requested by production personnel.
Issues final product labels and batch records to production.
Corresponds with customers via routine customer inquiries.
Provides support to intermediate labeling and tank inspections as needed.
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
Other duties as assigned with or without accommodation.
Participates in a certified 5S Workplace System to ensure good housekeeping and organization
Prioritizes and plans workload and team assignments to meet all internal and external customer needs for maximum efficiency and accuracy.
Effectively trains and works with others in a positive manner.
MINIMUM REQUIREMENTS:
Education:
High School Diploma, GED, or equivalent.
Associates of Science (AS) degree in a related field.
Bachelors of Science (BS) or equivalent life science degree preferred.
Experience:
Minimum of three years of experience preferred in a Quality auditing and batch record review role.
Preferred Skills/Qualifications:
Other Skills/Competencies:
Requires thorough knowledge of site quality procedures and GMP to appropriately audit and perform records functions associated with site compliance to FDA regulations.
Attention to detail, organization, time management, and effective communication are needed for this position.
RELATIONSHIP WITH OTHERS/ SCOPE:
Ability to understand the timely nature of work, quick reporting of results, and fast changing of priorities are necessary to complete assigned tasks.
Sound judgment must be used in evaluating plant compliance with GMP standards and initiative is required to facilitate changes needed. An error in judgment during audits could result in FDA citations to the company.
A good working relationship with various levels of personnel and management.
Good coaching skills are required when providing assistance and guidance to site internal auditors.
No employees directly reporting to this position.
WORKING CONDITIONS:
General normal office and meeting room conditions but must complete some routine assignments in plant and non-air conditioned production environment.
Ability to adjust schedule as needed to accommodate production, release, shipping needs.
Must be willing and able to wear PPE including hard-hat, steel-toed shoes, safety glasses and any other devices or equipment as specified for the position.
DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.
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.
$78k-97k yearly est. Auto-Apply 5d ago
Administrative Assistant III
Endo Pharmaceuticals Inc. 4.7
Raleigh, NC job
Why Us?
At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day.
Summary
The Administrative Coordinator provides administrative services and support for the Site Director, SLT and site staff.
Job Description
ESSENTIAL FUNCTIONS:
Perform administrative duties for Site Director, SLT and other staff members throughout the site.
Develop presentations, spreadsheets and other documents to support SLT and staff.
Coordinate meetings with visitors, customers, site celebrations, etc. Work with other MNK admin resources to organize/schedule site reviews.
Maintain site bulletin/communications boards with required postings.
Print and deliver MASL and Acetic Acid BOLs and track daily shipments to maintain up to date billing.
File and maintain all records for site materials receipts and deliveries including acetic acid, MASL, bulk chemicals, drums, bags, sulfuric acid etc.
Order office supplies for staff and operations teams.
Manage travel and accommodations for SLT and staff.
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
Manage small projects for Site Director, SLT and staff.
Maintain general office system & processes for mail, filing, and office workflow.
Collaborate with Human Resources to plan and coordinate employee engagement events.
Support HR for all new employee orientation processes
Coordinate lunches for site audits, reviews and other company functions.
Coordinate recognition lunches for employee service anniversaries (Quarter Century Luncheon).
Maintain company P Card and monthly reconciliation.
Attend SLT meetings and maintain meeting action log..
Maintain site organizational chart and employee photo book.
MINIMUM REQUIREMENTS:
Education:
High School diploma or equivalent required.
Associate degree or equivalent experience preferred.
Experience:
1 - 3 years of administrative experience in a pharmaceutical manufacturing environment.
Experience with meeting/event planning.
Experience supporting a Site Director or Executive and an entire site.
Preferred Skills/Qualifications:
Other Skills:
Competencies:
Must have exceptional organization and administrative skills. Excellent command of oral and written communications.
Requires a mature and self-directing individual, who can handle the wide variety of people and problems inherent in this job with poise and confidence.
Ability to develop work when presented a high-level work statement or concept.
High proficiency with Microsoft Office suites, (in particularly powerpoint and excel) and various other software tools is essential. Proficient at scheduling WebExs and Teams meetings .
Proficient in note taking and a quick study.
Trust & Integrity, Interpersonal Savvy, Written Communications, Comfort around Higher Management
RELATIONSHIP WITH OTHERS/ SCOPE:
Much of the work encountered is of a confidential and/or sensitive nature. Work for the Site Director is of a high priority nature requiring immediate action. Frequent interruptions via telephone or by visitors through the office.
Much of the communications with upper management flows through this position. Correspondence with others requires high accuracy or it can become the basis of lost time, confusion and poor decisions. Reservations and other travel arrangements demand near-perfect performance.
Wide, range of contact with others both within our plant and externally. All calls and visitors to the Site Director pass through this individual. Maturity, knowledge of proper protocol, tact, sensitivity, and good interpersonal relationship skills are necessary. Incumbent must use his/her initiative and judgment to handle or direct to proper individuals problems that develop in the absence of Site Director and plant staff.
WORKING CONDITIONS:
Most of work is done in an office environment. May be required to go out in the Plant occasionally.
Must be able to handle normal office equipment including computer, copier, and fax machine etc..
Must be willing and able to wear the required PPE, including hard-hat, steel-toed shoes, safety glasses, and other devices or equipment that is required.
DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.
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.
$26k-35k yearly est. Auto-Apply 3d ago
Pharmaceutical Operator I
Endo Pharmaceuticals Inc. 4.7
Raleigh, NC job
Why Us?
At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day.
Summary
This position is responsible for operating large scale manufacturing equipment to produce bulk APIs (Active Pharmaceutical Ingredients) in accordance with Company standards and operating procedures. He/she will be responsible for reports and documentation. Must be able to pay attention to detail due to the nature of chemicals and environment he/she will be working in on a daily basis.
Job Description
ESSENTIAL FUNCTIONS:
Operates in a regulated environment and complies with all cGMP and OSHA regulations applicable to manufacturing responsibilities. This includes understanding and following all applicable batch records, standard operating procedures and work instructions, and wearing appropriate personal protective equipment (PPE)
Operates and monitors reaction vessels, crystallizers, centrifuges, filters, evaporator, heat exchangers, pumps, valves and other equipment through manual operations, panel boards, indicators, and HMI displays (for PLC and DCS controls) following applicable batch records, procedures, and good documentation practices.
Operates and monitors hoists, dryers, mills, sifters, dust collectors, blowers, packaging stations, and other equipment through manual operations, panel boards, indicators, and HMI displays (for PLC controls) following applicable batch records, procedures, and good documentation practices.
Packages, weighs, samples, and labels finished goods and intermediate products following applicable batch records, procedures, and good documentation practices.
Maintains detailed operating reports and batch records, including notes on problems and records on added weights, volumes, measured temperatures, pH levels, pressures, and flow rates following applicable procedures and as directed by supervisor.
Operates forklifts, hoists, and other material handling devices to move bulk raw materials, WIP, and packaged goods to and from pick-up points.
Delivers samples to laboratory and retrieves operating supplies from storerooms.
Monitors environmental and safety devices (scrubber, rupture discs, relief valves, etc.) to ensure that the equipment is functioning properly.
Cleans and maintains work area, process equipment, tools and safety supplies according to regulatory and Company standards and operating procedures.
Participates in various employee involvement teams and committees, such as Area/Site Safety Teams, Kaizen events, and Cost Savings Teams, to improve the workplace, increase efficiency, and maximize productivity.
Performs Lock Out/Tag Out (LOTO) independently using personal lock.
Other duties as assigned by Management.
SKILL LEVEL:
Has a basic understanding of equipment and processes in their area of responsibility.
Can perform basic troubleshooting of equipment or process malfunctions in their area of responsibility.
Exercises judgment within defined procedures and practices to determine appropriate actions.
TYPICAL DEMONSTRATED PROFICIENCIES:
Works toward qualification in either all APAP Wet End operations or all APAP Drying Tower operations.
LEADERSHIP RESPONSIBILITIES:
No direct responsibility for the work of others
Normally receives general instructions on routine work and detailed instructions on new assignments.
MINIMUM REQUIREMENTS:
Education:
High School Diploma, GED, or equivalent required
Previous GMP manufacturing experience preferred
Experience:
Previous experience in a GMP manufacturing environment (preferred)
Preferred Skills/Qualifications:
Must be able to communicate effectively in both verbal and written formats.
Must be able to read and follow detailed instructions and procedures.
Must be able to perform basic math.
Must have a working knowledge of chemical and/or powder processing equipment and associated safety requirements.
Must possess sound problem solving and decision-making skills.
Must work in a team environment to perform job tasks and cover workstations during breaks and lunches
RELATIONSHIP WITH OTHERS/ SCOPE:
Reports to APAP Shift Supervisor in the APAP production department
No positions report directly to the APAP Pharmaceutical Operator I
Has frequent contact with: APAP production personnel, Quality (QA/QC), Safety and Maintenance
WORKING CONDITIONS:
Must be able to wear required Personal Protective Equipment (PPE), including hard hat, safety glasses, ear plugs, steel-toe boots, gloves, chemical resistant aprons and suits, and other personal protective equipment deemed necessary.
Must be able to lift and carry up to 50 pounds. Material handling devices (e.g., hand truck, fork truck, and conveyors) are used, when possible, but use of proper lifting and movement techniques is necessary to prevent injury.
Must be physically able to climb stairs and ladders, roll drums, lift and pour bags of raw materials, drive forklifts, etc.
Must be able to work in outdoor conditions as portions of the facility are not climate controlled.
Must be able to work rotating 12-hour shifts and overtime as needed.
DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.
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.
$36k-44k yearly est. Auto-Apply 3d ago
Sr. Predictive Maintenance Technician
Endo Pharmaceuticals Inc. 4.7
Raleigh, NC job
Why Us?
At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day.
Summary
The Sr. Predictive maintenance technician is responsible for executing the sites predictive maintenance program. Duties include collection and analysis of vibration, ultrasound, non-destructive examination and thermographic information for plant equipment, including but not limited to fans, blowers, electrical motors, pumps, gearboxes, compressors and conveyors. Perform precision maintenance on imbalanced fans, misaligned shaft couplings, loose, or weak bases, failed bearings, worn sheaves, improper mountings and improper lubrication. Ensure all plant assets are operating at optimal levels by developing new predictive techniques and programs for plant equipment. Own the lubrication program. Identify optimal operating conditions such as load, speed and environment with the proper lubricant, application frequency, the right amount and correct sealing arrangement in order to achieve the optimum equipment life.
Job Description
ESSENTIAL FUNCTIONS:
Works effectively with Reliability Engineers, Process Managers, and Maintenance leadership to troubleshoot and resolve equipment issues. Uses initiative to seek out root cause of failures and take steps to correct and prevent recurrences.
Report on developing fault conditions and provide corrective actions and severity estimates. Coordinate with the Planning group to ensure maintenance requirements are effectively communicated.
Assists in the RCFA corrective actions and helps eliminate chronic equipment issues.
Schedule and execute routes and inspections to maximize productivity.
Solicits recommendations from technicians and mechanics on improving existing procedures, routes, and Standard Job Plans.
Assists with perform post failure analysis to verify accuracy of fault identification in order to continuously improve diagnostic skills.
Reviews preliminary drawings, specifications, and plans from Engineering for accessibility for predictive and lubrication activities and recommends changes when necessary.
Facilitate the maintenance department employees in receiving necessary training to maintain and improve their skill levels. Works to maximize technician flexibility through cross-training.
Willingness to continue training as required to remain up to date on techniques, procedures, and practices.
Effectively understand and perform IR thermography, Vibration analysis, Ultrasonic scans, and Precision laser alignments.
Develop and present technical reports based on field data gathering.
Generate corrective work orders in the CMMS system and assign them appropriately for planning and scheduling based on gathered data.
Maintain and optimize the vibration analysis database.
Performs other duties as assigned by Maintenance management and/or designee.
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
Other duties as assigned with or without accommodation.
Assist CMMS admin with naming coordination between CMMS, P&ID's and field tags.
Ability to interact with supervisors, staff, vendors, and the public using a positive collaborative approach.
Ability to consistently complete assigned work while attending to multiple tasks and prioritizing projects to meet deadlines as directed.
Ability to problem solve and engage necessary staff/supervisors to address emerging facility issues.
Initiative and ability to work with minimal direction/monitoring; sound judgment and decision making capabilities are essential.
MINIMUM REQUIREMENTS:
Education:
High School Diploma, GED, or equivalent required.
Technical or Associate degree in a related field preferred.
Experience:
5+ years experience in maintenance in a manufacturing environment.
Must have a thorough knowledge of processes, equipment, and proper safety and environmental practices.
Must be familiar with standard operating procedures and process documentation.
Must be Vibration Data Collection and Analysis Level II certified
Preferred Skills/Qualifications:
Other Skills/Competencies:
Certifications in infrared and ultrasonic data collection and analysis.
Certification in SNT-TC-1A for UT, PT and/or MT.
Must be able to effectively communicate in both verbal and written formats.
Must have knowledge of basic hand tools.
Knowledge of cGMP requirements.
Able to plan and execute multiple projects simultaneously.
Works well with new technology and computer based data gathering equipment.
Must have strong computer skills (Microsoft Office, E-mail, data entry).
Learn on the Fly, Organized, Self-Motivated, Action Oriented, Problem Solving
RELATIONSHIP WITH OTHERS/ SCOPE:
Work is routinely reviewed by site management for adherence to objectives of the site.
Advises management on improvement projects and work orders, and safety or environmental hazards.
Internal contacts are made on a routine basis with the first line management in the Maintenance, Production, Engineering, Utilities, Warehouse, and Quality Control areas. With the diverse interaction with numerous groups, a tactful and diplomatic approach to communications is necessary in order to achieve the cooperation between individuals and departments.
Must be highly organized, self-motivated and have the flexibility to shift priorities quickly in a constantly changing work environment.
WORKING CONDITIONS:
The plant's open-air construction exposes employees to the normal year-round, outside climate. Some relief from the elements is available in the control rooms, offices, and break area.
Dirty conditions and chemical fumes are occasionally present in the work areas.
Corrosive, flammable, and toxic material, all which are normally handled in the plant, pose potential leak points for slips, trips and falls. Extra care must be taken while navigating the site.
Must handle average to heavy weight materials by hand. Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, but use of proper lifting and movement techniques is necessary to prevent injury.
Must be able to physically negotiate stairs and evacuation ladders, to wear and operate safety equipment, enter vessels, inspect equipment, drive forklifts.
Must be able to wear the required Personal Protective Equipment (PPE) as deemed necessary by EH&S, leadership team, corporate, or safety guidelines.
DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this
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.
$64k-92k yearly est. Auto-Apply 24d ago
QC Tech II
Endo 4.7
Raleigh, NC 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 Quality Tech II analyzes process samples as received and performs non-routine analysis as requested. She/he will analyze finished goods and raw materials by chemical, physical, and instrumental means to ensure quality as needed. She/he will typically work on a rotating shift schedule.
Job Description
ESSENTIAL FUNCTIONS:
Performs in process testing for internal customers.
Performs finished goods, returned goods, and stability testing for external customers as needed.
Performs specified analysis on all process controls samples and reports in a timely manner by telephone or computer entry using approved written procedures and proper laboratory techniques.
Performs specified analysis on all finished goods using approved written procedures and proper laboratory techniques as needed.
Maintains accurate and precise records of all laboratory analysis using appropriate Mallinckrodt recordkeeping system.
Troubleshoots and performs routine maintenance on laboratory instrumentation.
Prepares all standards and reagents needed for proper execution of analytical methods and procedures.
Prioritizes and plans workload to meet all internal and external customer needs for maximum efficiency and accuracy.
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
Assists in any non-routine analytical work needed to solve plant problems.
Works on solving problems and implementing improvements in a teaming environment.
Uses problem solving skills to help with failure investigations and testing problems.
Aids in performing any non-routine quality control related tasks such as resampling, raw material testing, and performing analysis needed to validate methods and equipment.
Participates in a certified 5S Workplace System to ensure good housekeeping and organization.
Assists with training others as needed.
Other duties as assigned with or without accommodation.
MINIMUM REQUIREMENTS:
Education:
Associates of Science (AS) or Bachelor of Science (BS) or equivalent life science degree preferred. Appropriate experience may be a suitable replacement for degree.
Experience:
1 - 3 years laboratory experience in a pharmaceutical manufacturing operation preferred. Working knowledge of cGMP is a plus.
Expected Skills/Qualifications:
Other Skills/Competencies:
Must be able to perform basic mathematical calculations.
Familiarity with basic laboratory procedures, equipment, and computer key punching.
Sound and correct technical judgments are required during routine analysis.
High degree of concentration is required.
Ability to differentiate colors, as demonstrated by passing a test designed to identify color blindness (such as the Ishihara test). If testing criteria are not met with
uncorrected vision, the use of color correcting glasses may be used as long as testing criteria are met while using them.
Functional/Technical Skills, Priority Setting, Written Communication
Customer Focus, Organizing
RELATIONSHIP WITH OTHERS/ SCOPE:
Laboratory technicians are responsible for communicating any uncompleted work to the next shift, as well as any immediate priorities.
Majority of work is performed independently without direct supervision. Non-routine results, observations, or analytical requests are brought to the attention of the appropriate management personnel.
Reports to Quality Testing and Release Manager.
Frequent interact with operators, engineers, and Quality management for reporting routine analytical results. Communication may be though radio, telephone, email, or in person.
Incorrect or inaccurate analyses can result in possible shipment of reject drug items to Mallinckrodt customers.
Customer-requested specifications and Mallinckrodt methods of analysis are considered confidential for marketing purposes.
Ability to understand the timely nature of work, quick reporting of results, and fast changing of priorities are necessary to complete assigned tasks. Laboratory employees must be able to work effectively under these conditions.
Completes all required Compliance trainings in a timely manner.
WORKING CONDITIONS:
Most work is performed in a well-equipped analytical laboratory complete with fume hoods, laboratory benches, analytical glassware, and instruments.
Boxes of solvents, compressed gas cylinders, old records, and reserve samples are stored in areas outside the laboratory and may require lifting and transporting to the laboratory area.
Exposure to fugitive emissions of chemicals typical for chemical operations.
Normal dexterity is required for routine handling of laboratory glassware and instruments. Colors must be well-visualized and slight differences in volumes of liquids in appropriate glassware distinguished.
Must be able to wear the required personal protective equipment (PPE), such as hard-hat, steel-toe shoes, safety glasses, and other equipment as deemed necessary by EH&S, leadership team, corporate, or safety guidelines for the position.
Must be able to work a rotating12 hour shift schedule of (7pm-7am / 7am-7pm) in addition to occasional overtime as needed.
DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.
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.
$29k-38k yearly est. Auto-Apply 59d ago
Sr. EHS Specialist
Endo Pharmaceuticals Inc. 4.7
Raleigh, NC job
Why Us?
At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day.
Summary
SUMMARY OF POSITION:
An integral member of the site EHS Department, whose primary responsibilities are to ensure a safe and healthy working environment through training, awareness, and compliance with various environmental, health, safety and security (EHSS) corporate policies, federal regulations, and other generally recognized standards and guidelines.
You must possess the proper skills in order to identify hazardous workplace conditions, remove hazards and/or protect employees through development and implementation of Job Safety Analyses (JSA's) and risk assessments, in an effort to continually improve the organization's safety culture.
The Sr. EHS Specialist will also assist the Environmental Engineer in the areas of air and water quality type activities as they relate to site activities and operating permits limits. You will be tasked with taking a lead role in revising and improving the site's EHS procedures and management systems.
Job Description
ESSENTIAL FUNCTIONS:
Ensures a safe and quality working environment through training, awareness, and compliance with safety SOP's, corporate standards and OSHA regulations
Assist with various EHSS inspections / audits including but not limited to state or federal agencies or required periodic 3rd party audits.
Leads efforts as a team member in analyzing and continually improving the site's Safety Culture.
Develops and mentors others in developing Job Safety analyses (JSA's) and risk assessments.
Monitors and takes effective steps to ensure that workplace conditions comply with applicable federal and state occupational safety and health standards.
Ensures that all required records are prepared and maintained.
Investigates and prepares required reports on injuries and incidents.
Conducts safe work procedures and other safety training courses.
Provides input on equipment installation, start-up operation, and trouble shooting.
Ensures accountability, transparency, and effective communication cross-functionally and within the safety team and the EHS Department while guaranteeing information is timely, clear and accurate.
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
Other duties as assigned with or without accommodation.
Develop and apply a strong technical knowledge of Albemarle's Policies and Procedures covering Health, Safety and Environment. Other functions may include Regulatory Reporting, Employee training, and assistance contractor management.
Key contributor for policy updates, creation, and implementation
Document and communicate EHS Expectations, Outcomes and Metrics.
Leading planning and execution of Risk Assessments and EHS Audits
Required to participate in department on-call schedule.
Assists with project reviews for compliance needs.
Assists with Emergency Response training and response activities.
Be an active member in the site's emergency response Incident Command Team
Participate in continuous improvement activities and champion change when faced with adversity while incorporating team input.
Supplies the highest level of internal and external customer service while having the ability to diplomatically challenge established procedures and systems.
MINIMUM REQUIREMENTS:
Education:
B.S. degree in Occupational, Safety, and Health Engineering or related safety/technical field.
Advanced degree and/or professional certification (CSP, CHMM, CIH, PE) is a plus.
Experience:
Minimum 5 - 10 years of experience as a EHS professional required.
Previous EHS experience in a pharmaceutical, chemical, or manufacturing environment working with hazardous materials preferred.
Experience in industrial hygiene monitoring activities, data interpretation and report writing.
Experience with internal and external audits and inspections for regulatory compliance.
Experience in developing and delivering personnel training
Skills/Qualifications:
Other Skills:
Competencies:
Must be able to walk, climb, and wear personal protective equipment (PPE) to include full body suit and respiratory equipment.
Working knowledge of Title 29, Code of Federal Regulations Part 1910 and Part 1926;
Working knowledge of various North Carolina Division of Environmental Quality regulations as they relate to Air Quality, Water Resources, and Waste Management.
Working knowledge of various NFPA, ASME, and similar industry standards/guidelines.
Skill in evaluating, planning (including strategic planning), organizing and reviewing regulations to determine compliance with various federal regulatory requirements and corporate EHS policies.
Ability to prepare and communicate technical data for use by a variety of different audiences, such as the Site Leadership, supervisors, senior engineers/scientists, technical expert, and operators.
Ability to use safety management and engineering practices for the continuous improvement of Plants TRR and workers compensation rates.
Excellent communication, interpersonal and technical writing skills.
Strong interpersonal skills.
Ability to handle multiple priorities.
Detail-oriented with the ability to work under tight deadlines.
Decision making, problem solving and analytical skills.
Conflict management skills.
Strong proficiency in Microsoft Office applications required..
Knowledge of FDA's Good Management Practices (cGMP)
Ability to effectively communicate with all levels of the organization, from operations to senior management, both oral and written format.
Action Oriented, Drive for Results, Problem Solving, Timely Decision Making,
Written Communications, Process Management, Time Management, Organizing
RELATIONSHIP WITH OTHERS/ SCOPE:
This position reports to the EHSS Manager.
The Sr. EHS Specialist supports the EHSS goals and functions of the pharmaceutical manufacturing facility.
This position interacts with all levels of the facility from production operators to senior site leadership.
Ability to effectively interact with manufacturing, maintenance, and medical departments.
WORKING CONDITIONS:
This position works both in the office and plant setting, both indoors and outdoors.
Outdoor conditions will include the temperature and weather extremes.
Work outside of normal business hours may be required including working early, staying after normal working hours, weekend work, or holiday work.
This position will rotate on-call duties, which include weekend/holiday coverage of plant operations.
Physical demands of this job include climbing stairs and extensive periods of walking and standing.
Exposure to fugitive emissions of chemicals typical for chemical operations.
Must be able don required personal protective equipment (PPE), such as hard hats, safety glasses, safety shoes, flame resistant clothing, respiratory protection, chemical protective suit, etc., as deemed necessary by EHS.
DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.
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.
$46k-64k yearly est. Auto-Apply 16d ago
Director, Parenteral Sterility Assurance
Eli Lilly and Company 4.6
Raleigh, NC job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity across the network.
The purpose of this position is to provide oversight and drive / maintain harmonization of technical programs that govern implementation and execution of Sterility Assurance control strategies across the Lilly Parenteral Network. This position also influences peers within Lilly globally and at the site level, as well as external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance, current expectations and business needs. This role also aids and enables building technical capability at Lilly sites to ensure the vital capabilities are developed and in place to meet business objectives. Finally, this role provides ad-hoc technical support to Lilly PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing.
Responsibilities:
* Assess differences in current sterility assurance programs across the sites and drive harmonization
* Work closely with site and multi-functional SMEs to drive cohesion. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved.
* Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved.
* Assume SME leadership role for a specific topic area within Sterility Assurance across the network, including harmonization of aspects of the topic area and facilitation of the knowledge across the network.
* Represent TS/MS on network Science Lead Team and other appropriate governance forums. Ensure that Sterility Assurance programs and similar topics are frequently presented to network team in order to align across sites. Ensure that learnings and best practices are shared across sites: set-up appropriate forums in order to achieve this and present case studies to site SMEs.
* Provide mentoring leadership to site SMEs to help build continue to build capability, particularly at the newer sites or where deep technical expertise is lacking.
* Building, maintaining, and growing capability across the organization in the sterility assurance space
* Provide technical support to new sites/ filling lines during design and start-up activities to ensure sterility assurance programs and process/ product requirements are supported at these sites, particularly while the sites are in early stages of building capability.
* Provide technical support for significant sterility assurance investigations to help identify root cause and implement appropriate corrective actions. Share best practices / learnings / CAPAs across the other sites.
* Benchmark industry trends and emerging regulatory guidance / requirements in the field through building an extensive peer network and attendance at relevant industry and regulatory meetings and advocacy groups. Advance Lilly agenda in the field. Represent Lilly on relevant external bodies related to Sterility Assurance; be influential in terms of representing Lilly's position on technical/ regulatory positions papers and guidance. Assess new technologies to ensure Lilly stays current with new trends and technologies and share with the network with the goal of staying current with industry best practice.
* Work with PR&D on new technology / platform development and implementation for pipeline products. Influence the agenda within PR&D to ensure the needs of Manufacturing are met, and the control strategies are fit for-purpose for robust and compliant commercial manufacturing.
* Provide ad-hoc technical support to Lilly organizations outside of the PPN including PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing.
* Engage in providing support during regulatory interactions such as RtQ of submissions, and on-site inspections
* Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals
Basic Qualifications:
* BS Degree required.
* MS/PhD in a biological science preferred.
* 10+ years' experience working in Parenteral Sterility Assurance / Environmental Monitoring or equivalent roles preferred.
* 10+ years' experience in parenteral manufacturing sterility assurance control systems - development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment preferred.
* Deep technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the parenteral manufacturing industry (e.g. filling technology, Annex 1 interpretation)
* Proficiency in data analysis, ability to prioritize, attention to detail, critical decision-making skills, complex problem-solving abilities
* Strong written and oral communication skills
* Ability to mentor and develop scientists in the fields of sterility assurance and applied pharmaceutical microbiology
* Understanding of cGMP's, policies, procedures, and guidelines relating to sterility assurance
* Demonstrated experience influencing site and network leaders to advance technical agenda projects
Additional Preferences:
* Work closely with senior technical staff in the parenteral network TSMS group to provide full oversight to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly the new sites. Provide guidance to investigations and ensure root cause, CAPA are quickly developed.
* Support the establishment of a sterility assurance network or hub in global TSMS
* Support inspection preparation and execution during health authority on-site or remote inspection as an expert in Sterility Assurance
* Experience in leading external committees or conferences to ensure Lilly remains a leader in the sterility assurance space
* Work with engineering SME's to support Lilly platforms to maximize the performance and minimize the risk of sterility assurance
* Strength in scientific and practical thinking to ensure the best options are selected following a thorough evaluation of applicable options.
* Strong capability to influence personnel and management across the organization
* Close interaction with quality to enable internal audits that identify risks
* Past experience in creating effective working relationships with all levels across internal and external stakeholders impacting the success of sterility assurance.
Additional Information:
* Approximately 25% travel
Lilly currently anticipates that the base salary for this position could range from between $133,500 to $220,000 and will depend, in part, on the successful candidate's qualifications for the role, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$133,500 - $246,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
$133.5k-220k yearly Auto-Apply 60d+ ago
Associate Principal, Business Analyst
Astrazeneca PLC 4.6
Durham, NC job
Are you ready to play a pivotal role in transforming demand forecasting within BioPharma ClinOps? As an Associate Principal, Business Analyst, you'll be at the forefront of developing, testing, and implementing FTE demand algorithms using PLANIT, our enterprise project management tool. Collaborate closely with stakeholders across BioPharma ClinOps to ensure alignment with organizational productivity initiatives and drive impactful changes in ways of working.
Accountabilities:
In this dynamic role, you'll deliver value by managing the BAU process for ongoing review and refinement of functional FTE demand algorithms. You'll develop and manage a roadmap of planned deliveries, ensuring alignment with scorecard objectives and functional needs. Your expertise will ensure that FTE BioPharma ClinOps demand in PLANIT (PLANISWARE Enterprise project management tool), aligns with the current organizational structure and is driven by reliable forecast algorithms. You'll also ensure the impact of productivity initiatives is realized in our demand forecasting, while delivering documentation, communication, and training to support ongoing changes.
Essential Skills/Experience:
* University degree at Bachelor level, in a scientific or business discipline
* 5-10 years of project/portfolio/resource management, in a Clinical Development environment
* Broad drug development experience in a matrix environment
* Minimum 5 years of working experience and understanding of business planning and capacity management process
* Ability to look for and champion more efficient and effective methods/processes
* Goal oriented and ability to drive performance
* Experience in converting organizational needs into demand algorithms
* Experience in developing demand algorithms for Clinical Development
* Strong data modelling skills and the ability to transform data into forms easily understood by others
* The ability to balance tact, patience and persistence with the need to move improvements at speed
* Strong organizational skills to move multiple functions through the improvement processes at different speeds based upon their level of understanding and complexity of their business
* Expert knowledge of PLANIT (PLANISWARE Enterprise project management tool), and demand algorithms
Desirable Skills/Experience:
* Advanced degree
* Business relationship management skills
* Accredited/Certified in Project Management tools/systems
* Proven ability with enterprise project management systems
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
At AstraZeneca, you'll be part of a team that tackles complex challenges head-on, empowered to innovate and experiment. With access to extensive capabilities and a comprehensive pipeline, you'll engage in diverse projects across the drug development process. Our supportive yet challenging environment fosters continuous learning and improvement, driving us towards groundbreaking solutions that make a tangible difference in patients' lives.
Ready to take on this exciting challenge? Apply now and be part of our journey to transform healthcare!
Date Posted
02-Jan-2026
Closing Date
30-Jan-2026
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
$120k-148k yearly est. 27d ago
Maintenance Pipefitter
Endo Pharmaceuticals Inc. 4.7
Raleigh, NC 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
We are seeking a skilled and safety-focused welder to join our team. The ideal candidate will have proven experience in pipe and plate welding along with metal fabrication. S/he has ability to interpret blueprints, project plans, and isometric drawings to complete pipe fitting and welding tasks. S/he must be able to accurately pre-fab and install pipe replacements and upgrades. This role requires strong technical knowledge, attention to detail, and the ability to collaborate with construction and maintenance teams to ensure safe, high-quality project execution.
Job Description
Blueprint and Drawing creation and interpretation
Create, read, and interpret project plans, blueprints, piping diagrams, and isometric drawings.
Translate written instructions and diagrams into precise fabrication and installation tasks.
Fabrication and Installation
Measure, cut, thread, groove, bend, and weld pipes according to specifications.
Prefabricate piping systems and confirm alignment, tolerances, and fit prior to installation.
Assemble pipes, fittings, and valves using appropriate tools, equipment, and joining techniques.
Understanding and experience with carbon steel, stainless steel (304L & 316L), aluminum, and alloy 20 metals, among others.
Ensure accurate pipe fit-up and compatibility with structural components.
Repair equipment in the field, as needed, including within confined spaces.
Testing and Quality Control
Inspect and test completed piping systems for leaks, durability, and compliance with industry standards.
Identify issues, perform adjustments, and report malfunctions or defects to supervisors.
Ensure adherence to project specifications, codes, and safety regulations.
Collaboration and Teamwork
Work closely with welders, fabricators, and construction crews to ensure seamless project integration.
Participate in failure analysis and troubleshooting to address causes of equipment or system failures.
Communicate effectively with supervisors, engineers, and team members.
Safety and Compliance
Support and follow all site safety programs, policies, and guidelines.
Wear and maintain all required Personal Protective Equipment (PPE), including full-face respirators, hard hats, safety glasses, gloves, steel-toe boots, and chemical-resistant gear when necessary.
Contribute to a safe work environment by practicing proper housekeeping in the shop and on job sites.
Equipment and Maintenance
Operate and maintain pipefitting machinery and tools (cutting torches, threading machines, grinders, calipers, etc.).
Ensure equipment is used safely and kept in good working condition.
Report any equipment malfunctions promptly.
Requirements
Minimum of 2 years' proven experience as a Pipe Fitter.
Strong ability to read and work from blueprints, isometric drawings, and piping diagrams.
Skilled in pipe fabrication, alignment, and installation processes.
Familiarity with welding processes and ability to collaborate with welders during fit-up and installation.
Proficiency in using tools and equipment such as cutters, threading machines, torches, squares, and calipers.
Ability to pass fit-up or pipefitting assessments as required.
Strong attention to detail with a results-driven and safety-focused approach.
Physical ability to stand, bend, squat, and lift heavy materials regularly.
Must be able to work in varying environmental conditions (indoor/outdoor, hot/cold, confined spaces).
Commitment to workplace safety and compliance with all PPE requirements.
Preferred Qualifications
Experience working on industrial, commercial, or construction piping systems.
Knowledge of relevant codes and standards (ASME, ANSI, OSHA, etc.).
Ability to weld pipe and plate using GTAW and SMAW methods when required.
Demonstrated teamwork and communication skills in a construction or industrial setting.
Ability to perform basic NDE techniques, such as visual examination and liquid dye penetrant examination.
Work Environment
This position involves work in both shop and field settings. Candidates must be able to adapt to changing work environments, including exposure to noise, dust, extreme temperatures, and confined spaces. Pipe Fitters must also be able to work at heights and in physically demanding conditions while maintaining strict adherence to safety standards. Shop and industrial manufacturing areas without climate control. Must be able to go up and down several flights of steps on occasion.
DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
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.
$54k-80k yearly est. Auto-Apply 60d+ ago
Principal Project Engineer
Endo Pharmaceuticals Inc. 4.7
Raleigh, NC job
Why Us?
At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day.
Summary
The Principal Project Engineer executes entire engineering projects of moderate-to-large size and of a complex nature. Independently performs most assignments with instructions as to what is generally expected. Interaction with the Production, Maintenance, and EHS (Environmental, Health, and Safety) Departments is critical for project success.
Job Description
ESSENTIAL FUNCTIONS:
Works with site departments in establishing scope and objectives of specific projects required to meet the business plan.
Works with site personnel to identify customer requirements and establish project objectives.
Develops project scope, cost estimates, schedules, and justification into a Capital Expenditure Request (CER). Responsible for capital projects ranging from $10,000 up to $5,000,000 per scope item.
Plans, conducts, and supervises assignments for execution of design and construction of major projects for the site. Ensures that projects meet scope, schedule, and budget.
Develops and implements department plans for executing capital projects and for providing site technical support.
Assists plant management staff in preparation of capital budgets.
Updates and reviews project spending forecasts monthly.
Assists in development of long-range plans for site capital spending with focus on continuous improvement and cost-savings.
Conducts recurring project status review meetings for scope, schedule and cost. Manages resolution of project issues or risks and communicates to stakeholders.
Selects and prepares equipment purchase specifications and construction specifications.
Performs the necessary reviews and takes action to maintain cost control and schedule control on assigned projects. Updates CERTS forecasting tool monthly.
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
Other duties as assigned with or without accommodation.
Ensures that capital projects are implemented meeting all throughput, mechanical, chemical, quality, and safety standards.
Provides technical support as needed for site.
Identifies resource needs to meet business objectives.
Identifies and implements cost savings.
Assists in the budgeting process.
Assists in selection of engineering design firms and construction contractors.
Serves as consultant to management.
MINIMUM REQUIREMENTS:
Education:
Must hold a B.S. in Chemical Engineering or related discipline.
Experience:
Minimum of 15 years of experience in production/process engineering design. Project experience is a plus.
Preferred Skills/Qualifications:
Other Skills:
Competencies:
5-10 years of experience in design and construction of projects preferred.
P.E. certification is a plus.
Must have a broad knowledge of principles and concepts in chemical processing, as well a good working knowledge in related engineering fields.
Should be proficient with word processing, spreadsheets, project scheduling, and database software on a PC.
Priority Setting, Organizing, Problem Solving, Interpersonal Savvy
RELATIONSHIP WITH OTHERS/ SCOPE:
Reports to Lead Project Engineer.
Significant interaction/communication with all site departments and corporate functions. Outside the company frequently selects/works with engineering design firms, manufacturer's representatives, and construction contractors.
Completed work is reviewed in terms of achieving objectives. Technical decisions on complex assignments are tested for soundness of judgment before initiating action. Otherwise operates with latitude for action.
WORKING CONDITIONS:
Position will work mostly in an office environment. Some work will be in the manufacturing plant, as necessary, to gather information, oversee projects, etc.
May be exposed to fugitive emissions of chemicals typical of chemical operations.
Must be able to climb stairs and ladders to review equipment during installation and troubleshooting.
Must be willing and able to wear PPE including hard hat, steel-toed shoes, safety glasses, hearing protection, and any other devices or equipment that is required.
DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.
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.
$129k-225k yearly est. Auto-Apply 3d ago
Sr. Operations Quality Engineer
Endo Pharmaceuticals Inc. 4.7
Raleigh, NC job
Why Us?
At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day.
Summary
The Sr. Quality Engineer has responsibility for interpreting and applying the applicable regulations and Quality Systems, and developing and implementing standard operating procedures (SOPs) and policies. In a cGMP manufacturing setting, provide Process / Quality Engineering support to all areas of the facility to ensure delivery of the highest quality product to the customer. The Sr. Quality Engineer will provide statistical and process support to assist with continuous improvement activities.
Job Description
ESSENTIAL FUNCTIONS:
The role provides input into regulatory filings as well as guidance for the various elements of the Quality System, including but not limited to the following: Validation, Deviations (Exceptions), Supplier Quality, Product complaints, Internal Audits, OOS, CAPA, Annual Product Review, Process control, Change Control, and identification/ recommendations for continuous improvement opportunities (internal/external). The Sr. Quality Engineer applies the appropriate statistical tools to analyze data, identify root cause and develop corrective actions for effective problem resolution of moderate to difficult scope and complexity.
Additional functional requirements:
Acts as SME for validation activities. Provides validation guidance and support for computer systems, production processes, and both production and laboratory equipment.
Acts as lead for Quality Systems ownership for day to day activities and monthly metrics and trending.
Provides guidance and training to Quality Department personnel in all applicable Quality Systems.
Leads compliance efforts for the site.
Provides direction and leadership for quality system improvements and for benchmarking of other sites to establish and implement best practices.
Participates in continuous improvement activities as required. May lead continuous improvement activities (e.g. kaizen).
Works within production teams, develop data trending models using appropriate statistical methods and deploy use of them.
Analyzes trends related to various activities and identify root causes and areas for improvement. Utilizes output of trend analysis to initiate investigations and or corrective/preventive action projects.
Assesses manufacturing and support processes to identify and implement quality minded efficiencies and improvements.
Leads or participates in risk analysis activities (FMEA) for changes to production or design processes. Uses process mapping tools to define critical control points and recommend alternatives to reduce risk of defects.
Oversees cross functional teams for complaint investigation and resolution. Generates final complaint investigation reports.
Leads investigation efforts and accurately document investigation plans, supporting data, and conclusions.
Leads corrective and preventive action projects.
Participates on extended core teams as a QA representative.
Statistical analysis (Excel, Mini-tab, other statistical software).
Develops sampling plans, as needed.
Provides change management guidance and support.
Provides internal / external audit support. May assume the Lead Auditor role.
Serves as a subject matter expert for Regulatory and Customer audits.
Conduct New Employee orientation.
Provides supplier quality oversight, including technical support for supplier selection and supplier quality evaluations as well as the development and management of supplier corrective action plans. Work closely with suppliers to ensure quality expectations and strengthen supplier relationships.
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
Other duties as assigned with or without accommodation.
Participates in a certified 5S Workplace System to ensure good housekeeping and organization.
Prioritizes and plans workload and team assignments to meet all internal and external customer needs for maximum efficiency and accuracy.
Effectively trains others in a positive manner.
MINIMUM REQUIREMENTS:
Education:
B.S. degree in Engineering or Science or a related field
Experience:
Minimum of 5 years' experience in QA/pharmaceutical manufacturing environment
Preferred Skills/Qualifications:
Other Skills/Competencies:
Knowledge of regulations associated with ICH Guidelines (Q7, Q8, Q9, and Q10), FDA, EMA, USP, EP, and JP.
Direct interactions with regulatory inspections.
Strong technical, oral, and written communication skills.
Able to speak, read, and write the English language.
Knowledge of Six Sigma Tools or certification.
Good project management, problem solving, team building, and negotiation skills. Good facilitation, presentation, and prioritization skills.
Ability to manage multiple projects.
Must have strong computer skills/knowledge and statistical skills as applicable to
Quality/Process Control.
Knowledge of SPC, DOE, FMEA, Six Sigma and Lean Manufacturing.
Individual must be self-motivated, able to achieve results with minimum supervision.
Command Skills, Action Oriented, Conflict Management, Customer Focus, Timely Decision Making, Functional / Technical Skills, Presentation Skills, Problem Solving, Priority Setting, Dealing With Ambiguity, Written Communication
CQE certification preferred, CQA certification preferred
RELATIONSHIP WITH OTHERS/ SCOPE:
This position consults with all levels of plant personnel on issues and projects as required. This position will also interact with personnel from other locations / positions within Mallinckrodt.
This position interacts with personnel outside the company on a customer and supplier level.
This position requires self-motivation and daily execution of tasks with limited supervision interaction.
WORKING CONDITIONS:
Generally normal office and meeting room conditions, but must complete some routine assignments in plant and non-air conditioned production environment.
Exposure to fugitive emissions of chemicals typical for chemical operations.
Position may require some travel.
Must be able wear the required Personal Protective Equipment (PPE) as deemed necessary by EH&S, leadership team, corporate, or safety guidelines.
DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.
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.
$99k-137k yearly est. Auto-Apply 5d ago
Director Scientific Communications and Engagement
Astrazeneca 4.6
Durham, NC job
The Director, Scientific Communications shapes and leads the long-term communications strategy for BioPharma Clinical Operations, elevating the visibility, reputation, and impact of BioPharma ClinOps across R&D and the enterprise. This strategic role partners directly with the Head of Clinical Operations and senior leadership to craft a compelling, science anchored narrative of how Clinical Operations accelerates innovative, patient centric development. The Director will steward integrated internal and external communications, thought leadership, leader visibility, and enterprise storytelling grounded in a deep understanding of clinical development, operational excellence, data/digital transformation, and compliance.
Role purpose
Build and execute a multiyear communications strategy for BioPharma Clinical Operations that aligns to R&D and enterprise strategy, advances change adoption, and measurably improves awareness, engagement, and influence.
Serve as a principal advisor and communications lead to the Head of Clinical Operations, providing counsel, executive messaging, and issues management.
Translate complex scientific and operational topics (trials portfolio, digital/data innovation, risk-based quality, patient engagement, sustainability) into clear, compelling narratives for diverse audiences.
Strengthen Clinical Operations' voice and presence inside R&D and across AstraZeneca, and externally with industry partners.
Key responsibilities
Strategy and leadership
Set the long-term BioPharma Clinical Operations communications vision, priorities, and annual operating plan, with clear KPIs tied to business outcomes (e.g. cycle time, quality culture, talent brand, innovation adoption).
Establish the strategic narrative and messaging architecture for ClinOps 2030, mission, proof points, and signature stories, ensuring consistency across channels and markets.
Advise and coach the Head of Clinical Operations and LT on executive communications, change leadership, and stakeholder engagement. Act as communication lead for LT meetings, town halls, and enterprise forums.
Partner with other Communications team members as an experienced peer, offering guidance, coaching, mentoring, and thought partnership while collaborating on priority initiatives without direct line management.
Partner with R&D, Corporate Affairs, SEN and HR to integrate ClinOps narratives into broader enterprise communications and employer brand.
Integrated communications and channels
Own the BioPharma ClinOps editorial calendar, content roadmap, and multichannel strategy (Workvivo posts, video, newsletters, podcasts, town halls, playbooks).
Lead development of high impact content: executive speeches, narratives, video series, infographics, thought leadership articles, and campaign toolkits.
Ensure compliance with regulatory, legal, IP, and data privacy requirements.
Map and manage critical stakeholder groups (ClinOps LT, functions, regions, sites, study teams via appropriate channels), tailor messaging to their needs and maturity.
Drive leader visibility and “leaders as communicators” programs, develop leader communication playbooks and coaching to cascade strategy and reinforce cultural behaviors.
Sponsor key events and flagship moments (ClinOps 2030 milestones, ClinOps Awards, innovation showcases) with measurable engagement and follow through.
Define success metrics across awareness, engagement, behavior change, and business impact.
Conduct audience insights, message testing, and channel analytics to continuously refine strategy, socialize learnings and scale proven practices.
Qualifications
Essential
Degree in Communications or Journalism.
5+ years' experience in strategic communications within complex, global organizations, including executive advisory and enterprise change communications.
Pharma R&D experience with direct clinical operations preferred
Proven track record building multiyear communications strategies with measurable business impact.
Experience navigating regulated environments and partnering with Medical/Legal/Regulatory for external content.
Executive presence, stakeholder influence, and the ability to simplify complexity for global audiences.
Strong command of digital channels and analytics; proficiency with content management, enterprise social, Adobe Creative Cloud, and video/podcast production workflows.
Desirable
Familiarity with AI assisted content, data storytelling, and measurement platforms.
When we put unexpected teams in the same room, we unleash ambitious thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
If you're ready to make a significant impact on patients' lives by joining a team that follows the science with curiosity and courage, apply today!
Date Posted
11-Dec-2025
Closing Date
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
$147k-201k yearly est. Auto-Apply 50d ago
Sr. Validation Engineer
Endo Pharmaceuticals Inc. 4.7
Raleigh, NC job
Why Us?
At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day.
Summary
Prepare and execute validation projects for all aspects of pharmaceutical API manufacturing to include Equipment Validation, Equipment Requalification, Process Validation, Packaging Validation, Cleaning Validation, Computer System Validation, and Data Integrity Analysis. Coordinates with cross-functional resources in the execution of cleaning validation projects and ensures compliance with FDA, EU, JP cGMP and any other appropriate regulations. Supports manufacturing, packaging and quality control with new equipment validation, process improvements, review and approval of change control documentation, review of exceptions related to deviations from cleaning processes and provides technical support as required. Ensures product quality through robust testing and process monitoring including use of statistical process control techniques, Six Sigma tools, understanding of current compliance and technology trends, and application of related pharmaceutical experience.
Job Description
Primary Job Functions:
Assists with multiple cross-functional projects from development through release to production. Projects include new facilities startup, manufacturing equipment and packaging line FATs and qualifications. Manage manufacturing and laboratory equipment requalification program. Assist in the management, support and continued development of the Cleaning Validation Program. Generate protocols, equipment swab diagrams, product risk assessments and general technical reports related to cleaning validation. Independently execute activities in support of the Validation Department cleaning validation program priorities with minimal guidance from the department manager. Establish and/or extend clean and soiled hold times. Analyzes data, utilizing appropriate statistical methods, generated by studies performed by the Validation Department to determine process capabilities. Support any deviations encountered associated with validation activities.
Secondary Job Functions:
Execute validations as needed, including assisting in product sampling, auditing and technical review functions as defined in study protocols. Review and approve change control documentation to assure all validation requirements are detailed in the Action Items. Ensures compliance with data integrity requirements.
Protocols & Reports Meet Organizational Requirements
Develops protocols using engineering experience and statistical process controls. Prepares and maintains validation records in accordance with department procedures to ensure compliance with current standards. Evaluates effectiveness of SOPs, identifies changes that would enhance the process, and ensures alignment with corporate procedures. Ensures compliance with FDA regulations and assists in audits.
Current with Industry Trends through Continuous Improvement
Stays current with regulatory requirements and creates remediation plans. Drives continuous improvement to stay aligned with industry trends. Works cross-functionally with team, other departments, and corporate validation to support improvements. Identifies and implements ways to streamline and improve efficiency while maintaining process effectiveness. Willing to challenge current practices. Experienced with using tools like an FMEA to use a risk based approach to determine and prioritize actions.
Minimum Requirements
Education:
Bachelor Degree in engineering discipline or technical field related to pharmaceutical manufacturing is preferred or Associates Degree with equivalent combination of education, experience, and competencies may be considered.
Experience:
Minimum of 5-10 years of previous validation experience in pharmaceutical manufacturing, with an emphasis on process and cleaning validation.
Preferred Skills/Competencies:
Extensive experience with process and cleaning validation.
Strong technical and mathematical aptitude.
Training or certifications in regulatory and cGMP requirements is desired.
Knowledge of FDA regulated drug validation requirements including knowledge of cGMP regulations in parts 201 and 2011, and FDA 21 CFR Part 11.
Other Skills/Competencies:
Strong computer literacy-MS office products, statistical analysis (Minitab) and database usage. Knowledge of statistical process controls is also required for equipment qualifications. Strong communication skills.
Attention to Detail: Is thorough and precise in accomplishing a task through concern for all the areas involved, no matter how small; monitors and checks work or information and plans and organizes time and resources efficiently; double-checks the accuracy of information and work product to provide accurate and consistent work; provides information on a timely basis and in a usable form to others who need to act on it; remains aware and takes care of details that are easy to overlook or dismiss as insignificant; compares observations of finished work to what is expected to find inconsistencies.
Project Management: Manages projects according to a standard process by using a systems development lifecycle; effectively directs and integrates all aspects of a project or program, ensuring that work progresses toward achieving goals and objectives; achieves expected results through the successful and timely completion of activities; at the end of a project, with project team, takes time to determine what was learned that can be applied to future projects.
Analytical: Uses a systematic approach in solving problems through analysis of problem and evaluation of alternate solutions; uses logic, mathematics, or other problem-solving tools in data analysis or in generating solutions; logically and thoughtfully sorts through ambiguity and alternatives with rigor and discipline that crystallizes ideas for action.
RELATIONSHIP WITH OTHERS/ SCOPE:
This position consults with all levels of plant personnel on issues and projects as required. This position will also interact with personnel from other locations / positions within Mallinckrodt.
This position interacts with personnel outside the company on a customer and supplier level.
This position requires self-motivation and daily execution of tasks with limited supervision interaction.
WORKING CONDITIONS:
Generally normal office and meeting room conditions, but must complete some routine assignments in plant and non-air conditioned production environment.
Exposure to fugitive emissions of chemicals typical for chemical operations.
Position may require some travel.
Must be able wear the required Personal Protective Equipment (PPE) as deemed necessary by EH&S, leadership team, corporate, or safety guidelines.
DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.
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.
$86k-110k yearly est. Auto-Apply 3d ago
Maintenance I/E Technician
Endo Pharmaceuticals Inc. 4.7
Raleigh, NC 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
SUMMARY OF POSITION:
The Maintenance I/E Technician performs a variety of electrical and instrumentation duties involving the maintenance of plant facilities. S/he will be responsible for calibrating, installing, maintaining, repairing, and inspecting plant monitoring devices on a wide variety of complex digital, analog, programmable, and other auxiliary equipment. Job Description
ESSENTIAL FUNCTIONS:
Installs, troubleshoots, repairs, and calibrates low voltage AC/DC electrical and instrumentation controls as well as 3-phase 480-volt power circuits.
Interfaces with OEM's and vendors as necessary. Requisitions equipment as needed.
Accurately completes all work performed according to standard operating procedures (SOPs) and work instructions, including proper documentation. Completes work orders using CMMS (Maximo) system.
Performs repairs and modifications as directed by maintenance supervisor, or other plant management.
Supports and participates in training programs.
Keeps the maintenance supervisor abreast of job status.
Supports site safety programs.
Supports/leads failure analysis process by discussing the causes of equipment failure with the maintenance supervisor, or the maintenance engineer.
Accurately completes all required paperwork, including but not limited to timesheets, “found as-left” forms, calibration reports (ICIR), and PM checklists.
Responsible for good housekeeping in the shop and at the job site.
Must be able to wear the required Personal Protective Equipment (PPE), full face respirator, hard hats, safety glasses, ear plugs, goggles, boots, steel -toe shoes, gloves, chemical resistant aprons and suits, and other personal protective equipment deemed necessary by EHS, leadership team, corporate, or safety guidelines for each job task.
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
Other duties as assigned with or without accommodations.
Supports the PM/PdM program and calibration program by ensuring a high quality of workmanship.
Accurately enters all required information on work orders.
Assists the maintenance supervisor and maintenance engineers, or others as needed with equipment installation, maintenance, repair techniques, and with identifying opportunities for improving equipment reliability. Shows emphasis on the design, installation, commissioning, maintenance, and use of mechanical equipment throughout the facility.
Recognizes problem independently and troubleshoots malfunctioning equipment without direct supervision.
MINIMUM REQUIREMENTS:
Education:
High School diploma, GED, or equivalent.
Associate or Technical degree in a mechanical field preferred.
Experience:
1 - 3 years I/E experience in a pharmaceutical manufacturing operation.
Preferred Skills/Qualifications:
Skills/Competencies:
Other Skills:
Work as an industrial I/E mechanic, PLC skills.
Must have a working knowledge of the tools and test equipment used for testing, calibrating, repairing, and maintain production instruments and controls.
Must be able to read and comprehend blueprints, electrical schematics, and engineering specifications.
Must be able to perform shop math.
Must be able to understand electricity, respect, and follow safety guidelines.
Must be able to read and follow written instruction.
Should be familiar with National Electrical Code, NFPA 70E, calibration standards, and cGMP.
Experience working with voltages up to 480.
Experience with CMMS, such as MP2 or Maximo.
Learning on the Fly, Problem Solving, Interpersonal Savvy
RELATIONSHIP WITH OTHERS/ SCOPE:
Reports to Maintenance Supervisor.
Utilizes a variety of test instruments, hand tools, supplies, and other shop equipment on a daily basis. On occasion, it may be required to take tools to the work area in the plant.
No direct responsibility exists for the works of others, although adherence to the team concept requires mutual assistance in some jobs.
Indirectly responsible for amount and quality of product through the maintenance and repair of production equipment. A thorough understanding of cGMP is critical.
Significant responsibility for the safety of others, improperly repaired equipment could possibly result in safety hazards to plant personnel.
Understands the misuse of processing equipment could result in serious injuries to self and others due to the potentially dangerous nature of the equipment and the chemicals being processed.
WORKING CONDITIONS:
I/E Technicians are required to work in all areas of the plant site, both inside and outside. There may be exposure to warm areas, dirt, oil, grease, chemicals/chemical fumes, and noise.
Injuries could result from spills or leaks or corrosive, flammable, and toxic material, all which are normally handled in the plant.
Dangers, such as sharp edges, pinch points, chemical and temperature burns, lifting, and electricity are often present. Personal protective equipment required to be worn often.
Routinely lifts and carries objects of 50 pounds or less in weight. Must be able to go up and down several flights of steps on occasion. May be required to exert effort to pull control valves, loosen bolts, or move controls and instrumentations.
DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.
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.
$53k-74k yearly est. Auto-Apply 60d+ ago
Maintenance Mechanic
Endo International 4.7
Raleigh, NC job
**Why Us?** At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day.
** Summary**
The Maintenance Mechanic performs a variety of mechanical tasks to install, maintain, repair, and troubleshoot plant equipment and site facilities.
**Job Description**
**ESSENTIAL FUNCTIONS** **:**
+ Installs, troubleshoots, and repairs process equipment, which includes hydraulic, pneumatic and mechanical systems to include pumps, gear reducers, fans, centrifuges, boilers, compressors, vacuum systems and a wide variety of facility equipment in a GMP environment.
+ Interfaces with OEM's and vendors as necessary. Requisitions equipment as needed.
+ Accurately completes all work performed according to standard operating procedures (SOPs) and work instructions (WIs), including proper documentation. Completes work orders using CMMS (Maximo) system.
+ Performs repairs and modifications as directed by Maintenance Supervisors and Plant Management.
+ Supports and participates in training programs.
+ Keeps the Maintenance Supervisors abreast of job status.
+ Supports site safety programs.
+ Supports/leads failure analysis process by discussing the causes of equipment failure with maintenance technicians, maintenance supervisors or the maintenance engineer.
+ Responsible for good housekeeping in the shop and at the job site.
+ Must be able to wear the required Personal Protective Equipment (PPE), full face respirator, hard hats, safety glasses, ear plugs, goggles, boots, steel -toe shoes, gloves, chemical resistant aprons and suits, and other personal protective equipment deemed necessary by EHS, leadership team, corporate or safety guidelines for each job task.
**DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:**
+ Other duties as assigned with or without accommodations.
+ Supports the PM/PdM program by ensuring a high quality of workmanship.
+ Accurately enters all required information on work orders.
+ Assists Maintenance Supervisors and Maintenance Engineers and others with equipment installation, repair techniques and identifying opportunities for improving equipment reliability. Show emphasis on the design, installation, commissioning, maintenance and use of mechanical equipment throughout the facility.
+ Recognizes problems independently and troubleshoots malfunctioning equipment without direct supervision.
**MINIMUM REQUIREMENTS** **:**
_Education:_
High School diploma, GED or equivalent.
Associate or Technical degree in a mechanical field preferred.
_Experience:_
1 - 3 years mechanical experience in a pharmaceutical manufacturing operation.
_Preferred Skills/Qualifications:_
_Skills/Competencies:_
_Other Skills:_
Welding skills.
Shaft Alignment
Precision Maintenance
Lubrication
Mechanical Seals
Pumps- Multiple types (Centrifugal, positive displacement, etc)
Gearboxes
Torque and its application
Must have knowledge of basic hand tools.
Must be able to perform basic math.
Must be able to read measuring tape, calipers and blueprints.
Must be able to read and follow written instruction.
Experience with a CMMS such as MP2 or Maximo.
Learning on the Fly, Problem Solving, Interpersonal Savvy
**RELATIONSHIP WITH OTHERS/ SCOPE:**
+ Reports to the Maintenance Supervisor.
+ Utilizes a variety of test instruments, hand tools, supplies and other shop equipment on a daily basis.
+ No direct responsibility exists for the works of others, although adherence to the team concept requires mutual assistance in some jobs.
+ Indirectly responsible for amount and quality of product through the maintenance and repair of production equipment. A thorough understanding of cGMP is critical.
+ Understands the misuse of processing equipment could result in serious injuries to self and others due to the potentially dangerous nature of the equipment and the chemicals being processed.
**WORKING CONDITIONS:**
+ Technicians are required to work in all areas of the plant site, both inside and outside. There may be exposure to warm areas, dirt, oil, grease, chemicals/chemical fumes and noise.
+ Injuries could result from spills or leaks or corrosive, flammable and toxic material, all which are normally handled in the plant.
+ Dangers such as sharp edges, pinch points, chemical and temperature burns, lifting and electricity are often present. Personal protective equipment required to be worn often.
+ Routinely lifts and carries objects of 50 pounds or less in weight. Must be able to go up and down several flights of steps on occasion. May be required to exert effort to pull control valves, loosen bolts or move controls and instrumentations.
+ May be required to wear a full-face respirator contingent upon required job duties.
**DISCLAIMER** **:**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
**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.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
$34k-49k yearly est. 17d ago
Chemical Process Engineer
Endo Pharmaceuticals Inc. 4.7
Raleigh, NC 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
Summary
SUMMARY OF POSITION:
The Production Engineer will function as a part of the APAP Operations Team. The Production Engineer will apply technical skills to manage day-to-day production, optimize plant operation, resolve operational issues, and investigate process deviations. The Production Engineer will provide technical assistance to the APAP manufacturing employees to ensure that production targets are met while complying with all applicable Safety and Quality rules and regulations
Job Description
ESSENTIAL FUNCTIONS:
Studies process and equipment to identify problems and opportunities. Provides technical guidance and instruction to APAP Operations Team regarding troubleshooting and debottlenecking efforts.
Ensures that all processes operate within defined and validated limits.
Conducts training for APAP Operations Team on new equipment and process changes.
Represents the APAP Operations Team in developing and implementing capital projects. Activities include project scoping, operating requirements, process controls, process tolerances, alarm rationalization, and validation.
Prepares periodic reports that summarize production rate, yield, rework status, quality condition and that summarize any special projects or problems that have been encountered.
Identifies and implements changes to reduce product cost by increasing production rate, improving yield, reducing downtime, improving equipment efficiency, etc.
Participates in periodic process audits with management personnel with respect to safety, environmental, quality, production, and cost.
Generates, reviews, and updates documentation for managing the process, including operating reports, batch records, P&IDs, etc. Reviews operating reports and batch records for accuracy and improvements.
Participates in customer and regulatory audits.
Investigates process deviations, inquiries, complaints and equipment loss incidents and identifies corrective and preventative actions where needed. Coordinates implementation of corrective measures.
Actively supports site continuous improvement process and serves on teams as needed to improve the workplace and increase efficiency and productivity.
Other duties as assigned with or without accommodation.
MINIMUM REQUIREMENTS:
Education:
Must have a B.S. in Chemical or Mechanical Engineering
Experience:
Must possess knowledge of chemical and chemical engineering principles in order to solve production, quality and throughput problems.
1-5 years of experience in chemical or bulk pharmaceutical (API) manufacturing operations
Preferred Skills/Qualifications:
Other Skills:
Competencies:
Understanding of GMPs (ICH Q7) and process validation
Understanding of Six Sigma and Lean Manufacturing tools and concepts
Experience in root cause analysis
Experience with change control / management of change
Demonstrated technical and leadership skills including oral/written communications, conflict resolution, decision making and sufficient financial acumen to interpret cost analyses and other reports
Ability to plan and execute tasks on multiple projects simultaneously
Must strive for continuous improvements in all work activities
Self-motivated, Action-oriented, Technical Skills, Problem Solving, Informing, Organizing
RELATIONSHIP WITH OTHERS/ SCOPE:
The Production Engineer will report to the APAP Focus Factory Manager
The Production Engineer will work closely with the other APAP Sr. Production Engineers, Supervisors and Sr. Day Operator to coordinate tasks
Frequent interactions with the following functions will be required:
APAP production operators
QA and QC
Maintenance and Engineering
EHS
Periodic interaction/communication with all site departments and corporate groups
May work with outside engineering design firms, manufacturer's representatives, vendors, and construction contractors
WORKING CONDITIONS:
Works in an office environment, but will spend significant time in a multi-story bulk pharmaceutical (API) manufacturing plant that is partly outdoors
May be exposed to fugitive emissions of chemicals typical of chemical operations
Must be able to climb stairs and ladders for equipment installation review, monitoring and troubleshooting.
Must be willing and able to wear PPE including hard-hat, steel-toed shoes, safety glasses, earplugs, fire-resistant clothing and any other devices or equipment that may be required
Position is required to be periodically available for on-call nights/weekends
DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.
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.
$86k-118k yearly est. Auto-Apply 60d+ ago
Process Engineering Intern - Durham, NC
Astrazeneca PLC 4.6
Durham, NC job
We are looking for undergraduate juniors and seniors majoring in Chemical Engineering, Chemistry, Biochemistry or a related discipline for a 12-week internship role in Durham, NC from May 18th to August 7th. * Support the design/development of innovative Process Analytical Technologies (PAT) and PoC study execution for both R&D and GMP spray drying processes.
* Assist in digital continuous improvement initiatives by strengthening in-silico process development tools. This includes developing robust integrations between the process data historian, data visualization dashboards, and predictive process models.
* Develop Lean SWI by establishing clear, detailed standard work instructions for critical manufacturing unit operations - under guidance and collaboration with Ops and Engineering team members.
* Support process development activities as needed.
Position Requirements:
* Undergraduate juniors and seniors majoring in Chemical Engineering, Chemistry, Biochemistry or a related discipline. Candidates must have an expected graduation date after August 2026.
* Process Engineering Fundamentals: Understanding of mass/energy balances, thermodynamics, and fluid dynamics required.
* Data Analytics & Visualization: Experience with tools like Python, MATLAB, or JMP for data analysis and dashboard development required.
* Process Modeling: Familiarity with first-principles modeling and simulation software (e.g., Aspen Plus, gPROMS) required.
* Digital Integration: Knowledge of data historians (e.g., OSIsoft PI) and linking process data to analytical models required.
* Pharmaceutical Manufacturing Exposure: Awareness of GMP principles and R&D workflows preferred.
* Problem-Solving & Continuous Improvement: Ability to apply structured approaches to optimize processes required.
* Communication & Collaboration: Comfortable working in cross-functional teams and presenting technical findings required.
* Ability to use and/or develop AI tools preferred.
* Ability to report onsite to Durham, NC 5 days per week. This role will not provide relocation assistance.
* US Work Authorization is required at time of application.
* This role will not be providing CPT support.
* Compensation range: $37 - $39 hourly.
Date Posted
09-Jan-2026
Closing Date
29-Jan-2026
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
$37-39 hourly 21d ago
Therapeutic Specialist Tzield, Raleigh, NC
Sanofi 4.3
Sanofi job in Raleigh, NC
Job title: Therapeutic Specialist Tzield, Raleigh, NC About the Job Therapeutic Specialist, Tzield are part of the National Tzield Sales Team and play a pivotal role in bringing a paradigm-shifting Type 1 Diabetes product to market. Therapeutic Specialists leverage their deep sales experience and expertise to accelerate Tzield adoption across providers and accounts and collaborate closely with all respective cross-functional partners. This role will develop territory-specific sales strategies, educate endocrinology and primary care providers on both Tzield and screening, and build a robust Tzield customer base.
We are an innovative global healthcare company with a focus on immunology that extends to innovation in diabetes and transplant medicine. Across different countries, our talented teams are determined to deliver a best-in-class customer experience using the best of digital, artificial intelligence and personal know-how. With a focus on immunology that extends to innovation in diabetes and transplant medicines, we pursue progress to make a real impact on millions of patients around the world.
Join the team transforming how healthcare is delivered for chronic and specialty conditions worldwide. In General Medicines, you'll help drive meaningful outcomes in diabetes, transplant, and immunology - with the scale and urgency patients deserve.
About Sanofi:
We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.
Main Responsibilities
* Brand Awareness & Intent to Treat with Endos.
* Build belief in Tzield mechanistic rationale and clinical narrative (e.g., MOA involving beta cell preservation, approved indication, efficacy / safety profile).
* Develop in-depth knowledge and understanding of key accounts across territory, including barriers to Tzield use.
* Contribute to priority account strategy development lead by SAMs and own execution to engage endocrinology and primary care providers on Tzield use.
* For non-priority Endo in territories, own the development and execution of growth-oriented account & business plans (e.g., account mapping, influence mapping, etc.).
* Identify account champions / KOLs and engage them as necessary and appropriate to communicate with peers and patients about Tzield.
* Screening Awareness & Development of T1D Ecosystem.
* Build belief in T1D early detection and importance of screening for T1D in asymptomatic, undiagnosed, early detection population.
* Conduct strategic planning at territory level to understand and contribute to development of broader T1D ecosystem in order to prioritize time, engagement, and education strategy.
* Contribute to screening strategy development and own execution to engage PCP / Ped on early detection & screening.
* Collaborate with stakeholders to identify and educate on importance of urgent referrals for identified patients within narrow treatment window.
* Educate relevant stakeholders on at-risk populations, screening / monitoring best practices, and the value of early detection (e.g., DKA avoidance).
Additional Responsibilities
* Collaborate closely with cross-functional Sanofi teams to support customers.
* Attending local, regional, and national meetings as directed.
* Maintaining strict adherence to all legal, regulatory, ethical, administrative, and financial duties.
* Achieving and exceeding assigned monthly, quarterly, and annual sales quotas.
About You
Qualifications
* B.A. / B.S. degree required.
* 3+ years of pharmaceutical, biotech or medical device sales experience.
* Account Management sales and / or rare specialty product experience.
* Demonstrated ability to understand and use data to drive improved business management and oversight of the sales within customer territories.
* Proven results of increasing educational awareness, provider adoption and customer engagement.
* Experience successfully launching products in the field.
* Experience collaborating and working in a matrix environment across multiple different sales, medical and support functions.
* Strong business acumen and solution-oriented mind-set
* Ability to strategically plan and execute work.
* Robust communication skills and ability to engage in two-way stakeholder dialogue.
* High accountability for all feedback, coaching, and results
* Valid driver's license.
* Ability to travel up to 80% of the time to customers, conventions, training, and other internal meetings.
Why Choose Us?
* Bring the miracles of science to life alongside a supportive, future-focused team.
* Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
* Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
* Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
* Help shape the future of care for chronic and complex conditions like aT1D, Type 2 diabetes, transplant, and cardiovascular disease.
* Be part of a simpler, digital- and AI-powered business that's rethinking how we work and engage with the world.
* Drive meaningful impact at global scale: our medicines reach more than 100 million people each year.
* Contribute to innovations that improve outcomes, relieve pressure on healthcare systems, and expand access worldwide.
This position is eligible for a company car through the Company's FLEET program. Candidates must complete all fleet safety training and must maintain an acceptable driving record regarding accidents and incidents.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
North America Applicants Only
The salary range for this position is:
$125,250.00 - $180,916.66
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.