Upsher-Smith Laboratories jobs in Maple Grove, MN - 77 jobs
Computer Systems Validation Specialist
Upsher-Smith Laboratories 4.7
Upsher-Smith Laboratories job in Maple Grove, MN
This position is responsible for establishing and maintaining the validated state for software-based computerized systems in use at Bora Pharmaceuticals Inc. according to the Validation Policy for Computerized Systems and in compliance with FDA and other regulatory requirements.
ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Establish working relationships with business units, IT and QA to provide appropriate support for their computerized systems validation requirements.
Participate in the generation of user requirements and facilitate the traceability from user requirement specifications to test scripts.
Support execution of test scripts and perform validation reviews.
Preparation of validation plans test plans, protocols, test scripts, reports, and other validation documentation, as requested.
Process computerized systems change control requests.
Assess validation impact for changes requested in software-based computerized systems.
Ensure appropriate documentation is maintained to support the status of validated, software-based computerized systems.
Perform administrative tasks for laboratory systems, including user account maintenance, record archival, troubleshooting, and periodic review.
Develop and maintain procedures for laboratory systems administrative functions.
Investigate unexpected events, classify Incidents and document their impact.
Ensure procedures and documentation requirements for change control, qualification and incident handling activities are followed according to approved SOP's.
Assist in vendor evaluations and audits, as requested.
Assist in regulatory audits, as requested.
Support revision of existing procedures as business needs change.
Maintain internal tracking logs and supporting documentation to ensure completeness and compliance with SOP's.
Stay current with changing business needs and validation requirements for the software-based computerized systems.
Perform internal audits on tracking logs and supporting documentation to ensure completeness and compliance with SOP's.
Perform risk assessments for new systems and upgrades to existing validated systems.
Assist with Quality Systems (eQMS, eDMS) activities, as needed.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.
EDUCATION, EXPERIENCE and SKILLS
Bachelor's degree with minimum 4 years' experience in pharmaceutical or medical device manufacturing validation or computer systems validation.
Associate's degree in a technical discipline (i.e. Math, Computer Science, Business) and 7 years' experience in pharmaceutical or medical device manufacturing validation or computer systems validation
Minimum 2 years pharmaceutical or medical device experience in computerized systems validation.
Other Knowledge, Skills and Abilities:
Working knowledge of ERP systems (SAP preferred), laboratory systems (e.g., Waters Empower, Dassault Systèmes Biovia eLN, PerkinElmer UV WinLab, Metrohm OMNIS), and Veeva QualityDocs electronic document management systems.
Understanding of cGMP and Part 11 regulations and documentation requirements.
Knowledge of network infrastructures, both physical and virtualized.
Working knowledge of SDLC principles.
Understanding of computer programming, (PLC/DCS) preferred.
Acclimated with Microsoft Office software applications (e.g. Word, Excel, PowerPoint, Access); Ability to read drawings (e.g. wiring/cabling, network architecture).
Compensation Range:
$75,789.00 - $113,684.00
Upsher-Smith Laboratories, LLC is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Upsher-Smith Laboratories, LLC will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.
$75.8k-113.7k yearly Auto-Apply 37d ago
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Laboratory Metrologist
Upsher-Smith Laboratories 4.7
Upsher-Smith Laboratories job in Maple Grove, MN
The Laboratory Metrologist is responsible for performing routine and non-routine calibrations and maintenance for equipment in the Upsher-Smith Analytical Laboratory with minimal support in compliance with cGMP, FDA and other regulatory requirements. Responsible for creation and execution of instrument qualification with support.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Essential Duties
Perform maintenance and calibrations for intermediate laboratory instruments (e.g. HPLC, UPLC, GC).
Subject matter expert for operation and troubleshooting of intermediate laboratory instruments.
Assess impact and provide recommendations for requested changes (Change Control) in qualified laboratory instruments with support.
Support and maintain the qualified state of laboratory instruments in compliance with USL, FDA and other regulatory requirements.
Write and execute qualification documents (IQ/OQ/PQ, etc.) and technical reports with support. Participate on project teams.
Intermediate understanding of USP chapters related to calibration and qualification of equipment with ability to evaluate proposed changes and their impact.
Author deviations with support.
Prioritize workload independently and tracks completion of high priority activities.
Plan maintenance and calibration activities around lab testing activities and be willing to shift priorities to meet business needs.
Ensure that tasks performed are consistent with company policies and Code of Conduct.
Correspond with outside vendors, compendial groups (USP, ICH, etc.) and other departments with minimal supervision.
Review and revise SOPs used for instrument operation/maintenance/calibration.
Manage project timelines with support and notify management if deadlines will not be met. Propose solutions to reduce the impact.
Provide leadership and training for junior calibration technicians.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.
Experience & Education Requirements
Bachelor's Degree in Chemistry, Engineering or related field with a minimum of 4 years' experience, in calibrating and maintaining HPLC, GC, IR, AA, and UV and other laboratory equipment, preferably in the pharmaceutical industry, OR;
Master's Degree a minimum of 2 years' experience in calibrating and maintaining HPLC, GC, IR, AA, and UV and other laboratory equipment. preferably in the pharmaceutical industry, OR;
High School Diploma or equivalent with 10 years' experience working in a laboratory setting, with a minimum of 4 years maintaining and/or calibrating laboratory equipment, preferably in a pharmaceutical industry.
Other Knowledge, Skills and Abilities
Demonstrate cooperation and professionalism with all members of the USL organization.
Aids in ensuring a safe environment in the laboratory.
Strong verbal and written communication skills, ability to work independently and with others and to multi-task.
Experience or training in Word or Excel and other computer software.
Required to wear safety glasses and lab coat while in the lab area, may be required to wear other protective equipment such as goggles, gloves, ear protection, etc.
Compensation Range:
$75,789.00 - $113,684.00
Upsher-Smith Laboratories, LLC is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Upsher-Smith Laboratories, LLC will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.
The Vaccine Customer Representative (VCR) supports customers by providing clinical information on our Company's vaccines, as well as education and resources. They do this to support customer operational and financial needs such as reimbursement information and contract adherence in an effort to help the provider or system increase their immunization rates among appropriate patients and help protect them from vaccine preventable diseases. The Vaccine Customer Representative (VCR) is the primary point of contact for a variety of customers within their assigned geography.
These customers may include health care providers such as physicians, nurses, pharmacists as well as quality directors, immunization managers, and office managers. Within their geography there are a diverse set of health care locations that they will call upon in order to execute their role including: clinics, health departments, integrated delivery systems, and hospitals.
The VCR is a key member of the local Customer Team that works collaboratively with other field-based employees such as the Vaccine Key Customer Leader (VKCL), Region Medical Director (RMD) as well as other members of the extended team.
The primary activities include:
+ Engaging in balanced product sales presentations with Health Care Providers and Health Care Business Professionals to align customer needs and our Company's vaccine attribute in accordance with product labeling, and CDC and professional society recommendations.
+ Providing Company Vaccine management with updates on customer needs as it relates to helping them improve patient health outcomes, customer feedback, marketplace dynamics, and progress towards quality goals.
+ Providing customers with key insights by keeping apprised of professional and health care environment knowledge through self-study of company-provided scientific, product and marketplace information, attendance at product workshops and conferences, as well as consistent and ongoing review of our Company's promotional materials.
+ Utilizing analytical skills and tools to engage customers in quarterly business reviews regarding their vaccine contract to educate customers on the best ways to maximize their contract performance across the Company portfolio.
+ Assisting customers with education to improve their organization's immunization rates through adherence to quality-based programs using appropriate tools such as Vaccine IQ.
+ Regularly monitoring their business performance against objectives using company provided tools.
+ Developing a territory level business plan that focuses on improving immunization rates with assigned customers in accordance with Our Company's policies, standards, and ethics.
+ Maintaining product knowledge and certification on the entire Company vaccine portfolio along with knowledge of the CDC immunization schedule for both pediatric and adult vaccines.
Specifically:
+ Within select customer accounts, acts as primary point of contact for the customer, meet with key customers/personnel to maintain understanding of their current practice structure, business model, and key influencers (Managed Care Organization/payers, employers, state policy), and their patients' needs. Identifies business opportunities and makes information available to relevant stakeholders to support the identified immunization needs.
+ For select customer accounts, coordinate with our Company's customer team (Account Executives, Integrated Delivery System team, Solutions support teams, etc.) to outline customer strategy for interactions/relationships aimed at improving immunization rates.
**Territory Information:**
+ This territory covers Mansfield, OH.
+ The ideal location to reside is within this territory.
+ Travel (%) varies based on candidate's location within the geography.
**Position Qualifications:**
**Education Minimum Requirements:**
+ Bachelor's Degree with 3 (36 months) or more years Sales experience **OR** a minimum of high school diploma with at least 6 years of equivalent experience which could include professional sales, experience in marketing, military or healthcare/scientific field that is not sales related (pharmaceutical, biotech, or medical devices).
**Required Skills:**
+ Demonstrated strong ability to build trust with customers and demonstrate value in selling situations through high-quality interactions which are focused on products/solutions with the common goal of improving health outcomes.
+ Demonstrated strong ability to divide customer population into groups of individuals who share similar characteristics and buying behaviors, and apply this information to focus on groups effectively, allocate promotional resources, and drive execution of commercial plans.
+ Demonstrated strong ability to understand customer's business climate, assess overall market potential, identify and prioritize unique opportunities and business risks in local markets, develop territory plans and follow up to drive business results in assigned geography or market.
+ Demonstrated strong ability to understand multiple interdependencies within an account, consider customer healthcare goals and needs, and maximize account performance by building long-term relationships through collaborative business planning processes and approaches.
+ Demonstrated strong ability to convey technical concepts accurately and clearly
+ Demonstrated high degree of tenacity to drive and achieve strong measurable results
+ Demonstrated strong ability to overcomes setbacks to meet or exceed objectives
+ Demonstrated strong pursuit of opportunities to learn and apply new skills to support the business
+ Demonstrated strong ability to be innovative by utilizing new or existing technologies
+ Demonstrated strong ability to use data to analyze trends to drive business results
**Other Requirements:**
+ Valid Driver's license
**Preferred Skills/Experience:**
+ Demonstrated strong ability to convey technical concepts accurately and clearly
+ Demonstrated strong understanding of Marketing/Sales &/or Marketing/Sales Support Functions/Operations
**Required Skills:**
Account Management, Account Management, Account Planning, Adaptability, Business Opportunities, Business Planning, Customer Accounts, Customer Education, Customer Experience Design, Customer Experience Management, Customer Feedback Management, Customer Strategy, Health Improvement, Health Outcomes, Hospital Sales, Interpersonal Relationships, Lead Generation, Managed Care, Market Analysis, Medical Affairs, Pharmaceutical Sales Training, Sales Calls, Sales Metrics, Sales Operations, Sales Pipeline Management {+ 4 more}
**Preferred Skills:**
Current Employees apply HERE (*****************************************************
Current Contingent Workers apply HERE (*****************************************************
**US and Puerto Rico Residents Only:**
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (******************************************************************************************
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (**********************************************
**U.S. Hybrid Work Model**
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
The salary range for this role is
$106,200.00 - $167,200.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** .
You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
**San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
**Search Firm Representatives Please Read Carefully**
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
**Employee Status:**
Regular
**Relocation:**
No relocation
**VISA Sponsorship:**
No
**Travel Requirements:**
10%
**Flexible Work Arrangements:**
Remote
**Shift:**
Not Indicated
**Valid Driving License:**
Yes
**Hazardous Material(s):**
n/a
**Job Posting End Date:**
02/3/2026
***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.**
**Requisition ID:** R382501
$52k-75k yearly est. 1d ago
Sr. Oncology Sales Representative - Mobile/Montgomery, AL
Merck 4.6
Saint Paul, MN job
Our Sales team support our customers by providing clinical information about products, educational information, clinical training programs and resources. We support healthcare providers and healthcare systems meet the goals of the patients in their communities.
Our Company's Oncology organization is dedicated to delivering breakthrough innovations that extend and improve the lives of cancer patients worldwide. Our team of dauntless, forward-thinking individuals achieves this through an unwavering commitment to supporting accessibility to medicine, providing new therapeutic procedures, and collaborating with governments and payers to ensure that people who need medicines have access to them. At our company, our focus is on innovation and launch execution excellence; we translate breakthrough science into innovative medicines that help people with cancer across the globe. As we continue to grow and define the Oncology market of the future, we are looking for dynamic, entrepreneurial individuals who thrive in a team environment and are driven to succeed.
The Oncology Sales Specialist is a key member of our customer facing organization and is responsible for partnering with customers to address identified needs, educating key stakeholders about our leading immunotherapy compound, and communicating our vision to the larger Oncology community.
+ This is a field-based sales position that will cover the **Mobile/Montgomery, AL** territory.
+ The selected candidate must reside within the territory.
+ Overnight travel may be required about 25% of the time.
+ Travel (%) varies based on candidate's location within the geography.
**General Responsibilities:**
+ Demonstrate in-depth knowledge of how to create a compelling and logical rationale for the value of products and how to contrast, compare, and position our company brand(s) versus competition using appropriate resources in informed discussions about products with HCP customers - knowing when/how to seek and provide additional information
+ Act as primary point of contact for customer. Meet with key customers/personnel to understand practice structure, business model, and key influencers.
+ Possess knowledge of cancer staging and possible treatment options and dosing schedules associated with different tumors/diseases, with comprehensive understanding of the impact of those options on the patient. Must understand impact and use of clinical trials in multiple tumor types/therapies, both in impact on promoted products and in practice behavior of the account.
+ Ability to analyze and identify trends in a complex buying environment. This includes the multiple channels of drug distribution, Oncology GPO's, wholesalers and specialty pharmacies. Review and evaluate patterns for products purchased and prescribed, outpatient vs in-patient infusion, as part of hospital contract, etc.
+ Demonstrate ability to understand complex account interdependencies in order to develop both short- and long-term account plans in conjunction with a wide array of stakeholders, proactively working with the account team and supervisor (known as the Customer Team Leader) to effectively execute the account plan. Share learnings and best-practices from one customer to help other customers meet their needs.
+ Influence beyond their specific geography or product area demonstrate advanced ability to ask strategic, insightful questions to obtain information on customer needs from all stakeholders in oncology accounts, using the insights to position our company Oncology brands and collaborate with customers on a customized strategy.
+ Collaborate and communicate effectively with extended "in-scope" customer team to ensure a consistent customer experience across our company's divisions and functional areas; ensure integration with the Key Account Manager, Nurse Educator, Field Reimbursement Associate, Medicare Account Executive, and other key stakeholders to share key customer learnings and support customer needs.
**Position Qualifications** **:**
**Minimum Requirements:**
+ Bachelor's degree with 6-8 years Sales experience OR a minimum of high school diploma with at least 10 years of equivalent experience
+ Equivalent experience can be: Professional sales experience, work experience in the healthcare/scientific field (including pharmaceutical, biotech, or medical devices) that is not sales related, professional marketing experience, or military experience
+ 2+ years of oncology field sales experience
+ Valid driver's license and ability to drive a motor vehicle
+ Travel the amount of time the role requires
**Preferred Experience and Skills:**
+ Documented history of strong performance in a sales / marketing or oncology clinical role
+ Clinical oncology experience across multiple solid tumors (Women's cancer - Breast, Ovarian, and Cervical)
+ Candidates with 0 - 2 years of oncology field sales experience will be hired at the S2 Oncology Sales Representative level.
+ Candidates with 2+ years of oncology field sales experience will be hired at the S3 Oncology Sales Specialist level.
oncosales
**Required Skills:**
Accountability, Account Management, Adaptability, Business Relationship Building, Business Relationship Management (BRM), Customer Engagement, Customer Experience Management, Customer Relationship Management (CRM), Data Analysis, Product Knowledge, Revenue Generation, Sales Forecasting, Sales Reporting, Sales Training, Service Excellence, Strategic Planning
**Preferred Skills:**
Oncology, Oncology Nursing, Oncology Sales
Current Employees apply HERE (*****************************************************
Current Contingent Workers apply HERE (*****************************************************
**US and Puerto Rico Residents Only:**
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (******************************************************************************************
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (**********************************************
**U.S. Hybrid Work Model**
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
The salary range for this role is
$156,900.00 - $247,000.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** .
You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
**San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
**Search Firm Representatives Please Read Carefully**
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
**Employee Status:**
Regular
**Relocation:**
No relocation
**VISA Sponsorship:**
No
**Travel Requirements:**
25%
**Flexible Work Arrangements:**
Remote
**Shift:**
Not Indicated
**Valid Driving License:**
Yes
**Hazardous Material(s):**
N/A
**Job Posting End Date:**
01/31/2026
***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.**
**Requisition ID:** R381669
$156.9k-247k yearly 8d ago
2026 Summer Internship Program: Data Scientist for RandD Quality Intern
Takeda Pharmaceutical Company Ltd. 4.7
Lexington, MN job
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide.
Objectives/Purpose:
* Assist in the implementation and management of AI and GenAI data products in alignment with R&D and enterprise stakeholders.
* Ensure compliance with company and regulatory requirements.
* Provide support in machine learning projects for complex and large-scale data analysis.
* Learn and contribute to machine learning frameworks in digital and innovation projects.
Accountabilities:
* Support the development and implementation of data models and algorithms for pharmaceutical quality and R&D.
* Assist in leveraging generative AI and large language models to enhance data analysis and automate processes.
* Collaborate with cross-functional teams to ensure data integrity and accuracy.
* Provide support in designing and delivering digital projects.
* Learn and help maintain GxP standards in alignment with Takeda Software Development Lifecycle policies.
* Prepare and present detailed reports and visualizations to stakeholders.
* Assist in the integration and advancement of AI technologies in R&D Quality.
* Support the development and implementation of strategic AI initiatives to enhance Quality Management Systems (QMS).
* Assist in overseeing AI-driven projects and ensure timely delivery.
* Foster a culture of innovation and collaboration.
Dimensions and Aspects:
* Technical/Functional Expertise: Basic knowledge of AI technologies in the pharmaceutical industry, experience with machine learning models, Agile methodologies, and GxPs.
* Leadership: Willingness to learn, strong relationship-building skills, and effective communication.
* Decision-making and Autonomy: Provide input to decisions and ensure swift implementation.
* Interaction: Experience working in teams and willingness to work in a global environment.
* Innovation: Support new ways of thinking and contribute to change.
* Complexity: High multicultural sensitivity and ability to navigate complex global ecosystems.
Education, Behavioral Competencies, and Skills:
* Pursuing a Bachelor's degree in Data Science, Statistics, Computational Biology, Bioinformatics, Computer Science, or a related field.
* Some experience or internships applying machine learning/deep learning in life sciences.
* Interest in AI-driven projects in a pharmaceutical or biotechnology setting.
* Familiarity with generative AI and large language models.
* Basic understanding of GxPs, regulatory requirements, and quality standards in the pharmaceutical industry.
* Strong problem-solving skills and attention to details.
* Excellent communication skills to convey complex information to non-technical stakeholders.
Internship Eligibility
* Must be authorized to work in the U.S. on a permanent basis without requiring sponsorship
* Must be currently enrolled in a degree program graduating December 2026 or later
* The internship program is 10-12 weeks depending on the two start dates (May 26th-August 14th or June 15th- August 21st)
* The intern must be able to commit to one of these time frames
* Able to work full time 40 hours a week during internship dates
* Takeda does not provide a housing stipend or relocation support for the U.S Summer Internship Program
Program Highlights:
* Hands-on experience with real projects and responsibilities
* Dedicated mentorship program pairing interns with experienced professionals
* Networking opportunities with industry professionals and fellow interns
* Internship events focused on professional and skills development
* Exposure to multiple business areas or departments within a Pharmaceutical Organization
Applications will be accepted between November 7th - January 2nd
Takeda Compensation and Benefits Summary
We understand compensation may be an important factor as you consider an internship opportunity. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Lexington, MA
U.S. Hourly Wage Range:
$21.00 - $46.00
The estimated hourly range reflects an anticipated range for this position. The actual hourly wage offered will depend on the candidate's school year/level to be entered following completion of internship. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. internship benefits vary by location and may include:
* Paid sick time
* Civic Duty paid time off
* Participation at company volunteer events
* Participation at company sponsored special events
* Access to on-site fitness center (where available)
* Commuter Benefit: To offset your work-commute expenses, Takeda provides U.S. employees with a fixed monthly subsidy to be used for either public transportation (transit) or parking.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
Lexington, MA
Worker Type
Employee
Worker Sub-Type
Paid Intern (Fixed Term) (Trainee)
Time Type
Full time
Job Exempt
No
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
$21-46 hourly 38d ago
Head Global Quality Device Compliance US/ROW region
Takeda Pharmaceutical Company Ltd. 4.7
Lexington, MN job
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
About the Role
As Head of Global Quality Device Compliance for the US and Rest of World region, you will provide strategic direction and oversight for GxP medical devices, including stand-alone devices, combination devices, and Software as a Medical Device (SaMD). You will ensure that Quality System requirements are established, effective, and maintained in compliance with all applicable regulatory requirements. This role partners closely with regional Device Compliance leads and cross-functional stakeholders to drive alignment and uphold Takeda's global device quality standards. You will play a key role in enabling innovation while protecting patient safety across the product lifecycle.
How You Contribute
* Provide strategic quality compliance direction and oversight for GxP medical devices, including stand-alone devices, combination devices, and Software as a Medical Device for the US and Rest Of World region (excluding EU, CAN, China, and Asia region).
* Serve as main quality compliance person with responsibilities for Device and Combination Products to ensure that the Quality System requirements are established, effective and maintained in accordance with all applicable US and ROW region regulatory requirements.
* Support oversight of compliant lifecycle management of GxP devices from R&D to discontinuation and establish a common framework and principles for Software as a Medical Device that enable safe innovation and protect patient safety.
* Partner with Device Compliance heads for the EU/CAN region and for the China/Asia region on all global device activities and support execution of global compliance strategies for Takeda Device and Combination Products in alignment with the overall 1-QMS approach.
* Support and execute applicable QMS processes supporting Device QMR responsibilities, including oversight of Device-related SOPs, quality councils, inspection support, and industry interactions.
* Partner with critical stakeholders in Regulatory Affairs, Device Quality, and PharmSci to ensure aligned and effective quality compliance strategies.
* Serve as Device Management Representative for US and Rest of World countries as needed and participate on teams developing global policies and procedures for Device and Combination Products.
* Be responsible for oversight of internal and external audits and inspections, including interactions with Notified Bodies and regulatory investigators, and assure tracking and completion of corrective actions.
* Attend Management Review and Quality Council for Device and Combination Products Quality Systems, assessing quality performance to demonstrate levels of control, capability, and compliance.
* Engage with stakeholders to enhance and execute sustainable Device Quality support for manufacture, packaging, testing, and release, ensuring compliance with GMPs, Takeda Quality Standards, and regulatory requirements.
What You Bring to Takeda
* Bachelor's degree in a scientific or technical discipline (advanced degree preferred).
* 7-10 years of experience in medical devices and/or combination products within a regulated healthcare environment, including 5-7 years in Quality Assurance or Compliance.
* Proven leadership experience (minimum 5 years) with the ability to mentor and coach teams.
* Expert knowledge of US and Rest of World regulatory requirements for Device and Combination Products.
* Experience with Class I, II, and III sterile and non-sterile medical devices and related regulatory filings.
* Strong analytical and risk-based decision-making skills, with the ability to address complex compliance challenges.
* Demonstrated success collaborating across global, cross-functional teams and regulatory authorities.
* A proactive, innovative mindset focused on continuous improvement and patient safety.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Empowering our people to shine:
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Lexington, MA
U.S. Base Salary Range:
$174,500.00 - $274,230.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
Lexington, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Exempt
Yes
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
$174.5k-274.2k yearly 60d+ ago
Manufacturing Lead Associate - Nights
Takeda Pharmaceutical Company Ltd. 4.7
Lexington, MN job
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
About the role:
As Manufacturing Lead Associate, you will deliver leadership and excellence in manufacturing processing and scheduling to meet site demands . Oversees floor operations to ensure safety, aseptic operations and compliance with cGMPs are maintained. Ensure efficient use of material and equipment and assign personnel in the execution of daily operations. Provide technical support through interactions with support groups to ensure accurate and well managed transfer of process changes/improvements to floor operations. Provide support to integrate best practices into manufacturing. You will report to Manufacturing Supervisor.
How you will contribute:
* Primary contact for troubleshooting, issue resolution or escalation; create and follow up on work orders; communicate daily scheduling and staffing plans, including reallocation of staff for breaks, lunch, and training.
* Provide oversight and execution of all routine and critical operations, including commissioning and validation activities; monitor material consumption and coordinate all material deliveries.
* Ensure documentation (forms, logbooks, form preps, batch records) is complete, reviewed, and meets good documentation practices; communicate schedule changes as needed; responsible for floor inventory.
* Recommend and implement process changes/improvements and safety or ergonomic improvements; ensure work is carried out safely, reporting safety issues and risks.
* Initiate deviations or investigations of various complexities; work with cross-functional teams to identify root causes, implement corrective actions, and complete GMP investigation/CAPA action items.
* Assist supervisor, engineer, or facilities with investigations; revise and author SOPs and batch records; communicate any quality issues or concerns to Supervisor and QA.
* Responsible for interviewing candidates; provide performance feedback; address minor personnel issues promptly and escalate major issues to the supervisor.
* Ensure staff compliance with relevant SOPs, batch records, form preps, and safety guidelines; act as a role model, subject matter expert (SME), and resource for staff; ensure safe work practices and behaviors.
What you bring to Takeda:
* Normally requires a high school diploma and 6+ years related industry experience or an Associates Degree in Life Sciences/Engineering field with 5 years of GMP Manufacturing experience.
* Biotech Certificate and prior leadership experience would be ideal.
* Experience with systems such as SAP, LIMS and TrackWise would be ideal.
* Perform manufacturing and sampling operations using aseptic technique
* Operational knowledge of Clean-in-Place (CIP) and Steam-in-place (SIP) Systems and general production equipment such as Autoclaves, water baths, pH/Conductivity meters etc.
* Knowledge of cGMP's and applicable agency regulations (such as the FDA, EMEA) to ensure inspection readiness of department.
* Demonstrates appropriate level of adaptability, maintains positive outlook, and demonstrates composure under pressure.
* In the absence of the supervisor they are the person of authority.
* Expected to act on behalf of the supervisor while on the floor
* Prior experience or exposure to standardization and measurements utilizing bench top equipment, aseptic processing, cell culture inoculation and scale up processes, use of bioreactors and centrifuges in the growth of cell cultures, process automation and SAP Enterprising Resource Platform.
Important Considerations:
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
* Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
* Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
* Work in a cold, wet environment.
* Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
* Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
* Flexibility to work according to the production schedule.
* Ability to lift, pull or push equipment requiring up to 25-50 lbs of force.
* Ability to stand for 6 hours in a production suite.
* Ability to climb ladders and work platforms.
* Stooping or bending to check or trouble-shoot equipment operations.
* Ability to work around chemicals (alcohols, acids & bases).
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
#GMSGQ #ZR1 #LI-MA1
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - MA - Lexington - BIO OPS
U.S. Hourly Wage Range:
$27.60 - $43.37
The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
USA - MA - Lexington - BIO OPS
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Exempt
No
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
$27.6-43.4 hourly 29d ago
Regional Medical Scientific Director (Medical Science Liaison) - GI Immunology (Upstate NY & CT) (Remote)
Merck 4.6
Saint Paul, MN job
Responsibilities** + The Regional Medical Scientific Director (RMSD) is a credentialed (i.e., PhD, PharmD, DNP, MD) therapeutic and disease expert who engages in bidirectional exchange of scientific or medical information with Scientific Leaders (SLs). This MSL-type role provides balanced, factual, scientific information about non-product areas of interest to the Company and replies to scientific questions from SLs, including questions about Company products. The work of an RMSD is aligned to: Scientific Exchange, Research, Scientific Congress Support, and Scientific Insights.
+ RMSDs liaise between the scientific community and the Company to enhance the comprehension of scientific foundations and goals for approved, in-development, and active Company-sponsored trials and/or investigator-sponsored research studies. The RMSD serves as a role model for other field medical team members in ways that include on-boarding and/or sharing of therapeutic expertise.
+ This position will support our Company's Gastrointestinal (GI) Immunology program
**Location:** The position covers the following exemplar states: Upstate New York (Rochester, Buffalo, Syracuse, Albany) and Connecticut. Candidates **must** reside within the territory; travel up to 50% within the territory.
**Responsibilities** **and Primary Activities**
**Scientific Exchange**
+ Develops professional relationships and engages with national and regional SLs to ensure access to company-approved medical and scientific information on areas of therapeutic interest and Company products
+ Conducts peer-to-peer scientific discussions and maintains a reliable presence with those SLs to ensure they have a medical contact within the company
+ Addresses scientific questions and directs SL inquiries on issues outside of RMSD scope (e.g., grants) to appropriate company resources consistent with applicable policies
+ Maintains current knowledge and comprehension of dynamic scientific and clinical environment in the Company's Areas of Interest (AOI) for the RMSD's specific therapeutic area.
**Research**
+ Upon request from Global Center for Scientific Affairs (GCSA),
+ Initiates discussions with SLs and/or potential investigators that include scientific/data exchange within our AOI to determine the alignment with our research strategies, studies concepts, scientific merit, and qualifications for a specific compound or trial
+ Enhances the comprehension of the scientific foundations and goals of investigator-sponsored research
+ Identifies barriers to patient enrollment and retention efforts to achieve study milestones
+ Upon request from Global Clinical Trial Operations (GCTO),
+ Recommends study sites and identifies potential investigators to participate in phase II-IV clinical development programs, conducts Site Initiation Visits (SIVs), and detects barriers to patient enrollment and retention efforts to achieve study milestones.
+ Protocol lead responsibilities in collaboration with GCTO
+ Addresses questions from investigators and provides information regarding participation in Company-sponsored clinical studies
**Scientific Congress Support**
+ Engages in scientific congresses and medical meetings, facilitates scientific and data exchange for both Company and competitor data.
**Scientific Insights**
+ Gathers feedback, data, or information during routine activities that can help the company better comprehend medical or scientific needs, priorities, or concerns of SLs and/or patients
**Inclusive Mindset and Behavior**
+ Demonstrates eagerness to contribute to an environment of belonging, inclusion, equity, and empowerment
+ Leads by example and serves as a role model for creating, leading, and retaining a diverse and inclusive workforce
**Required** **Qualifications** **, Skills, & Experience**
**Minimum**
+ PhD, PharmD, DNP, DO, or MD
+ Proven competence and a minimum of 3 years of relevant therapeutic area (Gastrointestinal) experience beyond that obtained in the terminal degree program
+ Ability to conduct doctoral-level discussions with key external stakeholders
+ Dedication to scientific excellence with a strong focus on scientific education and dialogue
+ Excellent stakeholder management, communication, and networking skills
+ A thorough comprehension of FDA, OIG, HIPAA, and other ethical guidelines, laws, and regulations relevant to the pharmaceutical industry and its customers
+ Ability to organize, prioritize, and work effectively in a constantly changing environment
+ Strong working knowledge of Microsoft Office Suite (Word, PowerPoint, Excel, Teams, OneNote)
+ Familiarity with virtual meeting platforms
+ Consistent adherence to field and corporate policies and Global Medical Scientific Affairs (GMSA) strategy, including field standard operating procedures (SOPs), Good Clinical Practice (GCP) guidelines, and administrative/operational responsibilities
**Preferred**
+ Field-based medical experience
+ Research Experience
+ Demonstrated record of scientific/medical publication
\#eligiblefor ERP
**Required Skills:**
Clinical Development, Clinical Immunology, Clinical Research, Clinical Trials, Gastroenterology, Gastrointestinal Disease, Immunoassays, Immunogenicity Assays, Inflammatory Bowel Diseases, KOL Engagement, Medical Affairs, Pharmaceutical Medical Affairs, Relationship Management, Scientific Research, Stakeholder Engagement, Stakeholder Management
**Preferred Skills:**
Current Employees apply HERE (*****************************************************
Current Contingent Workers apply HERE (*****************************************************
**US and Puerto Rico Residents Only:**
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (******************************************************************************************
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (**********************************************
**U.S. Hybrid Work Model**
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
The salary range for this role is
$190,800.00 - $300,300.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** .
You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
**San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
**Search Firm Representatives Please Read Carefully**
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
**Employee Status:**
Regular
**Relocation:**
No relocation
**VISA Sponsorship:**
No
**Travel Requirements:**
50%
**Flexible Work Arrangements:**
Remote
**Shift:**
Not Indicated
**Valid Driving License:**
Yes
**Hazardous Material(s):**
n/a
**Job Posting End Date:**
03/1/2026
***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.**
**Requisition ID:** R381387
$190.8k-300.3k yearly 7d ago
Senior Environmental, Health and Safety Specialist II
Takeda Pharmaceutical Company Ltd. 4.7
Lexington, MN job
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
About the role:
This is a key leadership opportunity for an experienced EHS professional ready to make a visible impact in a cutting-edge biopharmaceutical manufacturing environment. The Senior EHS Specialist II serves as a strategic EHS leader and technical expert partnering closely with manufacturing, laboratory, warehouse, and engineering teams to drive a proactive safety culture and ensure compliance excellence.
This position is ideal for an EHS professional who thrives in a collaborative environment, enjoys influencing without direct authority, and is motivated by solving complex problems, leading projects, and shaping the site's safety and sustainability journey.
How you will contribute:
* Be a Site Safety Leader: Partner with manufacturing and laboratory leaders to embed EHS into daily operations and build a culture of care, ownership, and accountability.
* Lead Core EHS Programs: Own high-impact programs such as Machine Guarding, LOTO, Confined Space, and Fall Protection. Develop and implement improvements that enhance compliance and reduce risk.
* Influence & Coach: Serve as a trusted EHS advisor for supervisors, engineers, and technicians. Coach others to identify hazards and implement sustainable solutions.
* Project Leadership: Act as EHS lead for large capital and engineering projects-ensuring safe design, construction, and startup.
* Incident Prevention & Investigation: Facilitate incident investigations with a focus on learning, root cause analysis, and continuous improvement.
* Data-Driven Improvements: Analyze EHS data, identify trends, and communicate performance insights to leadership for informed decision-making.
* Engage the Workforce: Lead site safety committees, mentor EHS champions, and partner with cross-functional teams to strengthen Takeda's high-performance safety culture.
Minimum Requirements/Qualifications:
* 10+ years' experience in the EHS field with a minimum of 3 years in a high pace/high volume manufacturing environment.
* BS/BA required in technical discipline: engineering, safety, industrial hygiene, environmental studies, life science or similar field.
* Professional certification (CSP, CIH, CHMM, etc.) and/or master's degree in a related field, preferred.
* Experience with ISO 14001, 45001 management systems, LEAN, Six Sigma methodology, preferred.
* Experience supporting technology transfers, process scale ups, and process hazard analysis, preferred.
Additional Considerations:
* This role is based in Lexington, MA with occasional travel to nearby sites.
* Work may include cleanroom gowning and PPE requirements, and occasional off-hour support for projects or emergencies.
* Ability to operate a car (valid driver's license) and travel via air, rail or other means of passenger conveyance.
* May involve occasional work in a cold, hot, high noise, at heights, or wet environment.
* Must be able to crouch, climb, lift, push, pull and carry up to 25 lbs. and remain standing or walking for extended periods.
* In general, the position requires a combination of sedentary work and walking around observing conditions.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - MA - Lexington - BIO OPS
U.S. Base Salary Range:
$111,800.00 - $175,670.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
USA - MA - Lexington - BIO OPS
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Exempt
Yes
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
$57k-75k yearly est. 60d+ ago
Phlebotomist
Takeda 4.7
Maple Grove, MN job
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers.
About the role:
Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a plasma donor screener and perform phlebotomy to support plasma center operations.
How you will contribute:
· You will answer phones, and greet and focus on our donors, while ensuring the safety of donors and our team.
· You will screen new and repeat donors and take and record donor vital signs and finger stick results.
· You will use our Donor Information System, prepare donor charts, maintain accurate records, and coordinate donor compensation.
· You will help identify operational opportunities for continuous improvement and initiate changes to center processes using company approved procedures.
· You will be there for our donors, which includes working a variety of shifts, Saturdays and Sundays, and holidays.
What you bring to Takeda:
· High school diploma or equivalent
· Ability to walk and/or stand for the entire work shift
· Will work evenings, weekends, and holidays
· Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees
· Ability to lift to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs.
· Fine motor coordination, depth perception, and ability to hear equipment from a distance
· Because of potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear
· 1 or more years minimum experience working in a customer or patient facing role is helpful
What Takeda can offer you:
Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include retirement benefits, medical/dental, family leave, disability insurance and more, all in a fast-paced, friendly environment.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.
BioLife Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - MN - Maple Grove
U.S. Starting Hourly Wage:
$18.00
The starting hourly wage reflects the actual starting rate for this position. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsUSA - MN - Maple GroveWorker TypeEmployeeWorker Sub-TypeRegularTime TypePart time
Job Exempt
No
$18 hourly Auto-Apply 8d ago
Legal Counsel - In House
Upsher-Smith Laboratories 4.7
Upsher-Smith Laboratories job in Maple Grove, MN
General Description
The Upsher-Smith Legal Counsel will provide strategic, proactive legal counsel to ensure compliant growth and risk management across the organization. This role enables the business to execute commercial strategies while meeting U.S. and global regulatory requirements. This position will be onsite/hybrid with residency in the Twin Cities metropolitan area.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Key Responsibilities
1) Commercial, Supply Chain, Licensing & Distribution Contracts & Transactions
Draft, review, and negotiate:
Sales & Distribution agreements (wholesalers, GPO's, drug chains, specialty distributors, 3PLs)
Market access agreements (rebate, chargeback, payer contracting)
Promotional services (agencies, speakers bureaus, MSL collaboration boundaries)
CDAs and the management of USL and 3rd Party confidential information
Vendor MSAs/SOWs, HCP consulting and advisory agreements, event sponsorships
Patient support program agreements (hubs, copay vendors, affordability programs)
Supply Chain (supply agreements, manufacturing agreements)
Purchase agreements including acquisition and divestiture agreements
Licensing and Development Agreements including external drug development and co-development agreements; Strategic Partnership Agreement
Maintain contract playbooks and clause libraries; align with Finance and Compliance.
2) Promotional & Advertising Legal Review
Serve as legal reviewer on Drug Promotion Review Team for claims substantiation, fair balance, use of real-world evidence, social/digital campaigns, and field tools.
Ensure alignment with FDA/FTC guidelines, product labeling, and risk communications.
3) Compliance & Ethics (Commercial)
Provide training to assure legal and regulatory compliance anti-trust, foreign and domestic anti-corruption laws, government programs including Medicare/Medicaid, FDCA, DSCSA, PDMA, Sunshine Laws, and other applicable state and federal laws, regulations and industry guidelines applicable to the Company and its Affiliates.
Interpret and operationalize False Claims Act, Sunshine Act/Open Payments, state marketing codes, and privacy requirements impacting commercial activities.
Partner with Director of Compliance to Advise on HCP interactions, meals/sponsorships, grants & donations, speaker programs, and field force conduct.
Partner with Director of Compliance to update policies, SOPs, and monitoring plans.
Work with, or oversee the work of the Legal Affairs.
4) Pricing, Market Access & Distribution
Review pricing strategies, rebate structures, patient affordability programs, and value-based contracting (as applicable).
Support trade strategy: GPO/IDN contracting, Retail/Wholesale GPO's, specialty pharmacy agreements, chargeback/reconciliation frameworks.
5) Investigations, Disputes & Outside Counsel Management
Lead internal fact-finding for commercial incidents, coordinate outside counsel for disputes, general litigation or regulatory inquiries.
This position oversees and manages general litigation activities including counsel selection, budgeting, litigation strategy, document production and interactions with outside counsel.
Manage legal holds, document preservation, and remediation plans.
6) Training, Enablement & Governance
Deliver onboarding and periodic training for Commercial teams.
Establish governance cadence (monthly risk reviews, quarterly policy updates) with Commercial leadership.
7) Strategic Partner with Leadership:
Recognize and anticipate a wide, and broad, variety of legal issues and business risks; communicate Company leadership the nature of issues and risks and recommend remediation plans.
Develop legal and business strategies with respect, or in response, to proposed business opportunities, legal developments and proposed legislation.
Stay abreast of and communicate industry laws, legal matters and regulations that impact strategy and business operations.
Responsible for maintaining a positive corporate legal posture and advising the leadership team on risk management.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.
Experience and Education Requirements
A Juris Doctor (JD); admitted to practice in Minnesota.
10 years of legal experience in the pharmaceutical, healthcare or medical device industry.
3 years In-House counsel experience.
Experience with commercial litigation and litigation strategy.
Technical expertise in contracts, promotional review, pricing/market access, HCP engagements, distribution/trade, and compliance frameworks.
Business-oriented judgment, negotiation excellence, stakeholder management, crisp written/oral communication, and project prioritization.
Track record of collaborating well with cross-functional colleagues.
Knowledge and ability to understand and apply laws and regulations; ability to analyze a situation and generate solutions.
Preferred Experience
Prior experience with generics and branded pharmaceuticals.
Experience with pre-launch commercialization, generic and rare specialty products.
Familiarity with global frameworks (e.g., HIPAA/Privacy, transparency regimes).
Exposure to digital and field sales promotion (social media, field CRM enablement, speaker programs, congresses) within regulated constraints.
Experience with supply chain, distribution and other 3rd party agreements.
Experience working in a global organization.
Working Conditions
Onsite/Hybrid position with residency in Twin Cities metropolitan area.
Travel: Minimal travel (
Work Hours: Align to commercial cadence; occasional evening/quarter-end workloads for contracting or launches. Occasional evening meetings to coordinate activities with Taiwan based HQ.
Compensation Range:
$196,304.00 - $294,455.00
Upsher-Smith Laboratories, LLC is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Upsher-Smith Laboratories, LLC will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.
$196.3k-294.5k yearly Auto-Apply 3d ago
Community Impact Liaison
Merck 4.6
Saint Paul, MN job
**Purpose of the Role:** Our Company has created the role of Community Impact Liaisons (CIL) to deepen its commitment to improving health outcomes in key U.S. communities. These roles will focus on strategic social investments that strengthen community-based health systems and address barriers to care-distinct from medical, policy, commercial or brand efforts. Specifically, this role will augment the community engagements our Company is already pursuing by investing in opportunities, including multi-year, that drive community improvements, bolstering the types of support provided to communities, including navigating care and increasing our presence at community-led events.
**Key Responsibilities of CILs:**
Reporting to the Director of Global Community Impact, this role will support grantmaking and collaborative partnerships at the local level in key communities who have been underserved (e.g. Appalachia). The candidate will work with internal and external partners to identify patient barriers and make social investments in community-based solutions.
**The Community Impact Liaison role will be a member of the Global Impact Investing and Giving (GIIG) function within SIS, which:**
+ Identifies high-impact social investments that support community partners working to improve health knowledge, pilot new models of care, strengthen the community health workforce, and build the capacity of health organizations and systems
+ Takes a whole-person health approach, recognizing the full range of social and environmental factors that impact health and well-being
+ Holds deep knowledge and broad networks in our Company's core therapeutic areas, with an emphasis on HIV and including oncology and cardiovascular diseases
+ Emphasizes a community-first approach, designing grantmaking strategies to ensure our work has impact on access to health that is responsive to community needs
**The candidate will be responsible for:**
+ **External Engagement:** Collaborate with Community-Based Organizations (CBOs), Non-Governmental Organizations (NGOs), and foundations to improve key health system strengthening outcomes for vulnerable groups.
+ **Local Presence:** Live and work in priority regions to build trust and relevance.
+ **Strategic Social Investment:** Identify opportunities and provide catalytic funding to initiatives like patient navigation and specialty care access programs.
+ **Convening Power:** Organize local events to foster collaboration among community stakeholders.
+ **Portfolio Oversight and Impact Monitoring and Measurement:** Monitor and interpret community health data as well asmanage, evaluate, and report on outputs and outcomes of a diverse set of community-based health initiatives that drive Access to Health goals.
+ **Cross-Functional Alignment:** Ensure efforts complement (not duplicate) work by Patient Innovation & Engagement (PI&E - our Research & Development division), and policy teams (HH and Corporate Affairs).
**Distinctive Features**
+ **Non-commercial:** Fully separated from our Company's commercial and brand activities.
+ **Catalytic Funding:** Designed to unlock sustainable, scalable community health solutions.
+ **Collaborative Leadership:** Work closely with internal leaders and external partners to drive impact.
**QUALIFICATIONS**
**Education:**
+ **Required** - BA/BS in Business, Marketing, Life Sciences, Public Health, Policy or related field
+ **Preferred** - Graduate degree in Public Health, Health Policy, or Allied Health fields
**Experience:**
+ 5+ years' experience working in community leadership or engagement role in health care systems or life sciences.
+ Experience collaborating with non-profit community-based organizations as well as city, county, or state health departments in identifying critical needs, aligning on shared goals, and negotiating mutual outcomes.
+ Experience in design and award of effective community grants - including identification of objectives and desired outcomes, development of Requests for Proposals, assessment of responses, Legal and Compliance reviews, contracting and reporting.
**Skills:**
+ Strong competency in independently translating community input and qualitative findings into impactful program designs
+ Capacity to synthesize community health epidemiology and social risk factors into practical recommendations for relevant evidence-based program strategies
+ Expertise in monitoring and interpreting community health data, including surveillance trends, and social determinants of health, to identify priority needs and emerging issues
+ Ability to work in a complex environment while driving systemic change through consensus-building, managing conflict, a deep understanding of the local context, and building trust with key stakeholders.
+ Analytical ability, business acumen, decision-making ability, and problem-solving skills
**Reporting to:** Director of Global Community Impact, Global Impact Investing and Giving, Social Impact and Sustainability
**Supervisory Responsibilities:** No
**Effort:** Full-time
**Required Skills:**
Building Consensus, Building Consensus, Business Acumen, Charitable Organizations, Collaborative Leadership, Communication, Communication Strategy Development, Community Connections, Community Health, Continuous Quality Improvement (CQI), Environmental Social And Governance (ESG), ESG Analysis, Fundraising Management, Health Sciences, Impact Investing, Inventory Management, Life Science, Marketing, Media Communications, NGO Management, Policy Development, Program Implementation, Public Health, Public Health Research, Request for Proposals (RFP) Development {+ 5 more}
**Preferred Skills:**
Current Employees apply HERE (*****************************************************
Current Contingent Workers apply HERE (*****************************************************
**US and Puerto Rico Residents Only:**
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (******************************************************************************************
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (**********************************************
**U.S. Hybrid Work Model**
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
The salary range for this role is
$126,500.00 - $199,100.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** .
You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
**San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
**Search Firm Representatives Please Read Carefully**
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
**Employee Status:**
Regular
**Relocation:**
**VISA Sponsorship:**
**Travel Requirements:**
**Flexible Work Arrangements:**
Remote
**Shift:**
**Valid Driving License:**
**Hazardous Material(s):**
**Job Posting End Date:**
01/29/2026
***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.**
**Requisition ID:** R378412
$55k-69k yearly est. 22d ago
Sr Automated Maintenance Technician - 1st Shift
Upsher-Smith Laboratories 4.7
Upsher-Smith Laboratories job in Maple Grove, MN
With minimal direction from the Lead Technicians and Maintenance Supervisor repairs, the Sr. Automated Machinery Technician maintains and assists operations from all departments to ensure Packaging Line and manufacturing equipment availability is maintained. Leads delegated projects. Completes required documentation to ensure compliance to cGMP's.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Essential Duties
Ensures own and others compliance with Current Good Manufacturing Practices, corporate policies, and procedures.
Provides direction to the department/shift in the absence of the Lead Technician.
Effectively troubleshoots and resolves difficult / advanced equipment issues utilizing a systematic logical approach until the root cause is identified.
Demonstrates the ability to train others.
Fabricates / repairs failed components as needed.
Advanced programming of electronic devices including: VFD's, PLC's, and other various controllers.
Designs / fabricates complex machinery to facilitate operations as needed.
Effective and efficient decision making and prioritization skills.
Identifies inefficiencies and improvements and offers effective solutions. Maintains adequate critical spare parts inventory for assigned functional areas.
Assists with the procurement of parts /quotes for budgeted items.
Coordinates and leads the installations of new equipment, modifications and enhancements.
Supports the engineering department with various projects and initiatives. Works with outside contractors/vendors.
Maintain and repair HVAC and supporting utility equipment.
Provides direction to department team members with complex issue resolution.
Creates troubleshooting /rebuilding documentation guides.
Provide support at meetings as directed.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.
Experience / Education Requirements:
A Vocational degree in automated machinery systems or equivalent from a two-year college and 5 years' experience; high school diploma (or equivalent) and 7 years' experience in a manufacturing/industrial environment (pharmaceutical, biotech, food manufacturer or electronics preferred). In addition to the Automated Machinery Technician's general requirement, advanced understanding/skills of: electronics, PLC programming, electrical controls, pneumatics, fluid power encoders /resolvers, stepper motors, servo drives, VFD's, control loops, thermocouples, and safety systems.
Certifications / Licenses:
Special Engineer Boiler license (or willingness to obtain one in the first 6 months in the position).
Other Knowledge, Skills and Abilities:
Proficiency using Microsoft Word and Excel programs. Advanced understanding of computer operating systems and file management. SAP knowledge desired. Strives to ensure a safe workplace by leading others to demonstrate compliance with the required PPE use; including footwear, hearing protection, eye protection, respirator protection, and electrical PPE and keeps the workplace clean and safe.
Travel: Occasional driving.
Compensation Range:
$56,919.00 - $85,379.00
Upsher-Smith Laboratories, LLC is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Upsher-Smith Laboratories, LLC will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
The Manufacturing Sciences Downstream group supports the development, transfer, and lifecycle management of purification and filtration unit operations used in biologics manufacturing. This team ensures robust downstream process performance by executing some process development, tech transfers, process validation, lifecycle management and evaluating new technologies for implementation. The downstream team designs and executes studies that will efficiently and accurately evaluate process changes or optimizations.
As an intern in the Manufacturing Sciences Downstream group, you will be immersed in a dynamic, cross-functional environment that bridges technical operations, quality control, and process development. This team plays a key role in ensuring the robustness and reliability of purification and filtration unit operations used throughout the lifecycle of biologic products-from early development through commercial manufacturing.
You'll be part of a collaborative group supporting process development, scale-down model generation, deviation investigations, and the evaluation and implementation of new technologies. Over the 12-week internship, you will own one or more projects and collaborate with your manager, mentor, and team members to execute them. This experience will help you build technical skills, scientific reasoning, and business acumen while contributing to the delivery of high-quality biologic therapies.
How You Will Contribute:
Duties may include some of the following, under the manager's and/or mentor's supervision:
* Support process development and optimization for biologics manufacturing.
* Assist with downstream lab activities, including documentation, data review, and performance tracking.
* Participate in scale-down model generation to simulate manufacturing conditions.
* Contribute to deviation investigations and root cause analyses.
* Help evaluate and implement new technologies to enhance analytical capabilities and data integrity.
* Collaborate cross-functionally with Quality Control, Manufacturing, and Quality teams.
* Gain exposure to GMP documentation practices and regulatory expectations in a biologics setting.
Internship Development Opportunities:
Interns will gain exposure to:
* Operating within industry guidelines for controlled scientific experiments.
* Approaches to solving real-world problems in drug development.
* An introduction to regulatory requirements for biologics manufacturing.
* Purification and filtration techniques commonly used in biologics production.
Job Requirements:
* This is a full-time, on-site position (40 hours/week).
* Must be pursuing a Bachelor's or Master's degree in a scientific or engineering discipline.
* Prior laboratory experience required (e.g., academic lab courses, guided research).
* Comfortable working in a dynamic environment where plans may evolve.
* Confident in working with and interpreting scientific data.
Internship Eligibility
* Must be authorized to work in the U.S. on a permanent basis without requiring sponsorship
* Must be currently enrolled in a degree program graduating December 2026 or later
* The internship program is 10-12 weeks depending on the two start dates (May 26th-August 14th or June 15th- August 21st)
* The intern must be able to commit to one of these time frames
* Able to work full time 40 hours a week during internship dates
* Takeda does not provide a housing stipend or relocation support for the U.S Summer Internship Program
Program Highlights:
* Hands-on experience with real projects and responsibilities
* Dedicated mentorship program pairing interns with experienced professionals
* Networking opportunities with industry professionals and fellow interns
* Internship events focused on professional and skills development
* Exposure to multiple business areas or departments within a Pharmaceutical Organization
Applications will be accepted between November 7th - January 2nd
Takeda Compensation and Benefits Summary
We understand compensation may be an important factor as you consider an internship opportunity. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Brooklyn Park, MN
U.S. Hourly Wage Range:
$21.00 - $46.00
The estimated hourly range reflects an anticipated range for this position. The actual hourly wage offered will depend on the candidate's school year/level to be entered following completion of internship. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. internship benefits vary by location and may include:
* Paid sick time
* Civic Duty paid time off
* Participation at company volunteer events
* Participation at company sponsored special events
* Access to on-site fitness center (where available)
* Commuter Benefit: To offset your work-commute expenses, Takeda provides U.S. employees with a fixed monthly subsidy to be used for either public transportation (transit) or parking.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
Brooklyn Park, MN
Worker Type
Employee
Worker Sub-Type
Paid Intern (Fixed Term) (Trainee)
Time Type
Full time
Job Exempt
No
$21-46 hourly 60d+ ago
Site Microbiologist
Takeda Pharmaceuticals 4.7
Brooklyn Park, MN job
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice (************************************** and Terms of Use (********************************************* . I further attest that all information I submit in my employment application is true to the best of my knowledge.
**Job Description**
About the role:
As the Site Microbiologist, you will oversee activities within the facility to ensure the microbial quality, safety, and compliance of pharmaceutical products, raw materials, utilities, cleanrooms, and manufacturing processes. You will support routine operations, investigations, environmental monitoring (EM), contamination control strategies (CCS), method development, and regulatory compliance within GMP environments. You will hold a PhD in Microbiology or a related field and have experience in virology within a regulated environment. You will report into the Site Quality Head.
**How you will contribute:**
+ Perform and/or oversee microbiological testing including bioburden, endotoxin, sterility testing, microbial identification, growth promotion, and water system monitoring
+ Ensure all testing complies with GMP, SOPs, and pharmacopeial standards
+ Oversee troubleshooting and qualification of microbiology laboratory equipment and advanced microbial detection systems
+ Manage the Environmental Monitoring (EM) program, including trend analysis, alert/action limit review, and CAPA activity
+ Support and continuously improve the site's Contamination Control Strategy (CCS)
+ Supervise personnel monitoring, viable and non-viable particulate monitoring, and surface sampling in compliance with EU GMP Annex 1 and FDA guidance
+ Lead microbiology-related investigations, including EM excursions, OOS/OOT results, sterility failures, and water-system deviations
+ Provide microbiological expertise in risk assessments, CAPAs, change controls, and root cause analyses
+ Collaborate with QA, Engineering, and Operations to proactively identify and mitigate contamination risks.
**Minimum Requirements/Qualifications:**
+ PhD in Microbiology, Virology, Biotechnology, or a closely related life sciences discipline
+ 3-7 years of experience in pharmaceutical microbiology
+ 3+ years of experience with GMP, aseptic processing, and regulatory microbiology requirements
+ 3+ years of experience in environmental monitoring, sterility assurance, and contamination control
**More about us:**
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
**Takeda Compensation and Benefits Summary**
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
**For Location:**
Brooklyn Park, MN
**U.S. Base Salary Range:**
$111,800.00 - $175,670.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
**EEO Statement**
_Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._
**Locations**
Brooklyn Park, MN
**Worker Type**
Employee
**Worker Sub-Type**
Regular
**Time Type**
Full time
**Job Exempt**
Yes
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice (************************************** and Terms of Use (********************************************* . I further attest that all information I submit in my employment application is true to the best of my knowledge.
**Job Description**
The Manufacturing Sciences Downstream group supports the development, transfer, and lifecycle management of purification and filtration unit operations used in biologics manufacturing. This team ensures robust downstream process performance by executing some process development, tech transfers, process validation, lifecycle management and evaluating new technologies for implementation. The downstream team designs and executes studies that will efficiently and accurately evaluate process changes or optimizations.
As an intern in the Manufacturing Sciences Downstream group, you will be immersed in a dynamic, cross-functional environment that bridges technical operations, quality control, and process development. This team plays a key role in ensuring the robustness and reliability of purification and filtration unit operations used throughout the lifecycle of biologic products-from early development through commercial manufacturing.
You'll be part of a collaborative group supporting process development, scale-down model generation, deviation investigations, and the evaluation and implementation of new technologies. Over the 12-week internship, you will own one or more projects and collaborate with your manager, mentor, and team members to execute them. This experience will help you build technical skills, scientific reasoning, and business acumen while contributing to the delivery of high-quality biologic therapies.
**How You Will Contribute:**
Duties may include some of the following, under the manager's and/or mentor's supervision:
+ Support process development and optimization for biologics manufacturing.
+ Assist with downstream lab activities, including documentation, data review, and performance tracking.
+ Participate in scale-down model generation to simulate manufacturing conditions.
+ Contribute to deviation investigations and root cause analyses.
+ Help evaluate and implement new technologies to enhance analytical capabilities and data integrity.
+ Collaborate cross-functionally with Quality Control, Manufacturing, and Quality teams.
+ Gain exposure to GMP documentation practices and regulatory expectations in a biologics setting.
**Internship Development Opportunities:**
Interns will gain exposure to:
+ Operating within industry guidelines for controlled scientific experiments.
+ Approaches to solving real-world problems in drug development.
+ An introduction to regulatory requirements for biologics manufacturing.
+ Purification and filtration techniques commonly used in biologics production.
**Job Requirements:**
+ This is a full-time, on-site position (40 hours/week).
+ Must be pursuing a Bachelor's or Master's degree in a scientific or engineering discipline.
+ Prior laboratory experience required (e.g., academic lab courses, guided research).
+ Comfortable working in a dynamic environment where plans may evolve.
+ Confident in working with and interpreting scientific data.
**Internship Eligibility**
+ Must be authorized to work in the U.S. on a permanent basis without requiring sponsorship
+ Must be currently enrolled in a degree program graduating December 2026 or later
+ The internship program is 10-12 weeks depending on the two start dates (May 26th-August 14th or June 15th- August 21st)
+ The intern must be able to commit to one of these time frames
+ Able to work full time 40 hours a week during internship dates
+ Takeda does not provide a housing stipend or relocation support for the U.S Summer Internship Program
** ** **Program Highlights:**
+ Hands-on experience with real projects and responsibilities
+ Dedicated mentorship program pairing interns with experienced professionals
+ Networking opportunities with industry professionals and fellow interns
+ Internship events focused on professional and skills development
+ Exposure to multiple business areas or departments within a Pharmaceutical Organization
Applications will be accepted between November 7th - January 2nd
**Takeda Compensation and Benefits** **Summary**
We understand compensation may be an important factor as you consider an internship opportunity. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
**For Location:**
Brooklyn Park, MN
**U.S. Hourly Wage Range:**
$21.00 - $46.00
The estimated hourly range reflects an anticipated range for this position. The actual hourly wage offered will depend on the candidate's school year/level to be entered following completion of internship. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. internship benefits vary by location and may include:
+ Paid sick time
+ Civic Duty paid time off
+ Participation at company volunteer events
+ Participation at company sponsored special events
+ Access to on-site fitness center (where available)
+ Commuter Benefit: To offset your work-commute expenses, Takeda provides U.S. employees with a fixed monthly subsidy to be used for either public transportation (transit) or parking.
**EEO Statement**
_Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._
**Locations**
Brooklyn Park, MN
**Worker Type**
Employee
**Worker Sub-Type**
Paid Intern (Fixed Term) (Trainee)
**Time Type**
Full time
**Job Exempt**
No
$31k-37k yearly est. 60d+ ago
Senior Director, National Accounts
Sarepta Therapeutics 4.8
Minneapolis, MN job
Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
We're looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
What Sarepta Offers
At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:
Physical and Emotional Wellness
Financial Wellness
Support for Caregivers
For a full list of our comprehensive benefits, see our website: *******************************
The Importance of the Role
The Senior Director of National Accounts, is responsible for creating, implementing and executing account level business plans for assigned regions and accounts. This individual may live in any state; travel 40-60% (dependent upon home base location). Ideally, the candidate for this role would be located in the central part of the US (ex. Minnesota, Chicago, Texas)
The position will also work closely with members of the broader Commercial organization including Marketing, Finance, and Managed Markets, as well as other cross-functional partners as appropriate.
The Opportunity to Make a Difference
Create, maintain, implement, and execute account level business plans for Payer (Commercial, Medicaid, Medicare and PBM) accounts; these customers include, but are not limited to C-suite, pharmacy directors, national and regional medical directors, formulary directors, clinical pharmacists, contract managers, claims processors and case managers.
Lead/advises opportunities with development, maintenance, and improvement of medical policy.
Obtain and maintain access for Sarepta's DMD product with Payers and PBMs in commercial, managed & Fee-for-Service Medicaid, and Health Insurance Marketplace lines of business.
Work cross-functionally within the Market Access team and with Sales, Marketing, Customer Care, Patient Support, Commercial Operations, Regulatory, Legal, Finance, Technical Operations, Market Research, Medical Affairs, and Human Resources to ensure corporate product objectives are met. Functions as a core cross-functional team member with responsibility/ownership of key aspects of complex projects.
Provide marketplace feedback in a timely manner to corporate management on customer business trends, competitive updates, and industry issues and opportunities.
Informs and collaborates with payers to prepare, educate, and assess the perceived value of future product launches and anticipate product coverage and sharing insights internally.
Other related duties as needed.
More about You
BA/BS required, advanced degree preferred.
15+ years of national/regional account management experience with current relationships in key accounts.
Payer (Commercial, Medicaid, and Managed Medicaid) and PBM account management experience required.
Experience with Buy and Bill (J-Codes) required.
Medical Policy and Contracting experience required.
Prior sales and/or marketing within the ultra-orphan biopharmaceutical industry preferred.
Exhibits strong business acumen.
Ability to think strategically across a portfolio of products in various life cycle stages and pricing implications.
Must be a highly motivated individual that is able to work cross-functionally with field sales and government affairs team in order to accomplish objectives.
Proven success in new product launches with Payers and PBMs.
Demonstrates ability to manage internal and external relationships.
Displays willingness to collaborate with internal colleagues as well as success exhibiting peer leadership.
Self-directed with ability to work in an autonomous work environment.
Demonstrates commitment to corporate philosophy and values.
The successful candidate must exhibit professionalism, strength in goal attainment, flexibility, problem solving, be confident.
Valid driver's license and in good standing.
Ability to travel up to 60%.
What Now?
We're always looking for solution-oriented, critical thinkers.
So, if you're comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.
#LI-Hybrid#LI-ES1This position is hybrid, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.The targeted salary range for this position is $247,200 - $309,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.Candidates must be authorized to work in the U.S.Sarepta Therapeutics offers a competitive compensation and benefit package.Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
$105k-142k yearly est. Auto-Apply 16d ago
Automation Maintenance Technician - 1st Shift
Upsher-Smith Laboratories 4.7
Upsher-Smith Laboratories job in Maple Grove, MN
With moderate direction from the Lead Technicians and Maintenance Supervisor, the Automated Maintenance Technician - 1st Shift repairs, maintains and assists operations from all departments to ensure Packaging Line and Manufacturing equipment availability is maintained. Plans projects as directed by leadership. Completes required documentation to ensure compliance to cGMP's.
Essential Duties:
Ensures self and others are in compliance with Current Good Manufacturing Practices, corporate policies, and procedures.
Effectively troubleshoots and resolves difficult / advanced equipment issues utilizing a systematic logical approach until the root cause is identified and corrective and preventive actions are known.
Fabricates / repairs failed components as needed.
Intermediate-level programming of electronic devices including: VFD's, PLC's, and other various controllers.
Assists with the setup and operation of equipment.
Identifies inefficiencies and improvements and offers effective solutions.
Maintains adequate critical spare parts inventory for assigned functional areas.
Assists with the procurement of parts /quotes for budgeted items.
Assists in the coordination of the installations of new equipment, modifications and enhancements.
Supports the engineering department with various projects and initiatives.
Works with outside contractors/vendors.
Maintain and repair HVAC and supporting utility equipment.
Performs / assists in the creation of calibrations, certifications and PM's for the equipment.
Provides direction to Maintenance Technicians with complex issue resolution.
Creates troubleshooting /rebuilding documentation guides.
Provide support at meetings as directed.
Requirements:
Vocational degree in automated machinery systems
Or
Equivalent from a two year college with an emphasis in electronics, mechanics or technology and 0 - 3 years related experience
Or
High school diploma (or equivalent) and 5 years' experience in a manufacturing/industrial environment (pharmaceutical, biotech, food manufacturer or electronics preferred)
Demonstrated experience working with electrical controls, electronics and fabrication skills In addition to the Maintenance Technician's general requirements, demonstrated proficiency and understanding/skills of: electronics, PLC programming, electrical controls, pneumatics, fluid power encoders /resolvers, stepper motors, servo drives, VFD's, control loops, thermocouples, safety systems.
Other Knowledge, Skills and Abilities:
Decision making skills: Decisive and able to correctly make informed decisions.
Computer Literacy: Proficiency using Microsoft Word and Excel programs. Advanced understanding of computer operating systems, file management, batch files and SAP knowledge desired.
Safety / best practices: Demonstrates own and ensures others compliance with the required PPE use; including footwear, hearing protection, eye protection, respirator protection, and electrical PPE and keeps the workplace clean and safe.
Certifications / Licenses:
Special Engineer Boiler License (or be willing to obtain one in the first 6 months of the position)
Compensation Range:
$51,745.00 - $77,617.00
Upsher-Smith Laboratories, LLC is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Upsher-Smith Laboratories, LLC will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.
$51.7k-77.6k yearly Auto-Apply 60d+ ago
Sr. Project Engineer - Pharmaceutical Engineering
Upsher-Smith Laboratories 4.7
Upsher-Smith Laboratories job in Maple Grove, MN
The Sr. Project Engineer plans, directs, and leads the activities of complex engineering projects in a pharmaceutical manufacturing/packaging and development environment to ensure that goals and objectives are accomplished within prescribed time and funding parameters. Interviews and selects contractors based on project requirements. Establishes and maintains schedules and budgets for each phase of the project. Works with internal and external project resources to outline work plan and to assign duties, responsibilities, and scope of work. Reviews status reports with various departments and modifies the schedules or plans as required. Prepares project reports and provides management updates. Leads project teams with cross-functional members to achieve successful outcome. Demonstrates ability to effectively problem solve and negotiate with others to achieve project goals. Exhibits creative and effective ways to resolve complex issues. Utilizes professional concepts and expertise to analyze situations or data and provide meaningful evaluations. Demonstrates a thorough understanding of industry practices and company policies and procedures. Participates as a technical subject matter expertise during internal and external meetings.
This is a hybrid role - candidates must be local.
Essential Duties
Manages and leads CapEx and continuous improvement projects, identifying set-up time reduction, inefficiencies and areas of waste in the manufacturing process.
Manages. prepares and presents cost estimates and justifications sufficient to attain project funding.
Manages project capital spending within established norms. Provides financial reports as required.
Coordinates the design and construction of new facilities and facility upgrades.
Generate, review and maintain project, construction and technical documentation, including P&IDs, Process Flow Diagrams and Specifications. Evaluate, design and arrange production equipment within production facilities to ensure the most efficient and productive plant layout.
Manages documentation program for engineering documents.
Leads project activities and resources with a focus on critical milestones to ensure effective and timely execution of project plans.
Investigates new equipment and technologies in the pre-planning stages of a project and determine the appropriate equipment for the application.
Reviews technical reports and documents for accuracy/content and approve final documents.
Provides production support engineering for high volume production equipment used on new and existing products and processes.
Provides technical support and solutions for manufacturing related initiatives including investigations and closures of Deviations and CAPAs.
Education / Experience Requirements
Bachelor's degree in Mechanical Engineering, Chemical Engineering or related engineering discipline. A minimum of 9 years' engineering experience in a manufacturing environment required. Experienced in cGMP Solid Oral Dose pharmaceutical manufacturing / packaging equipment, processes and facility operations strongly desired. Project planning and project leadership and design/building construction experience strongly desired.
Other Knowledge, Skills and Abilities
Demonstrated ability to lead projects and/or participate on project teams; ability to collaborate and work productively with others in a team environment; professionally represents self and Company when working with vendors, suppliers and customers. Ability to resolve complex problems and optimize machine performance; ability to manage project requirements and meet project deadlines; strong ability to analyze and interpret data and demonstrate exceptional problem-solving skills; ability to work independently with minimal supervision; understands and demonstrates the ability to follow Standard Operating Procedures (SOPs). Computer Aided Design (CAD) knowledge desirable.
Certifications / Licenses
Professional Engineering license or EIT certification preferred.
Travel Requirements
Up to 25%
Compensation Range:
$110,895.00 - $166,342.00
Upsher-Smith Laboratories, LLC is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Upsher-Smith Laboratories, LLC will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.
$110.9k-166.3k yearly Auto-Apply 44d ago
Sr Therapeutic Specialist, Oncology - Minneapolis
Gilead Sciences, Inc. 4.5
Minneapolis, MN job
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.
We set and achieve bold ambitions in our fight against the world's most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.
This unique opportunity supports the Minneapolis territory. As a Sr Therapeutic Specialist, Oncology at Gilead you will ...
Key Responsibilities:
* Responsible for representing Oncology products and services to a defined customer base, generating and growing sales, and consistently achieving or exceeding sales targets within a specific geographic area
* Prepare a business plan for your territory to achieve goals and initiate systems to monitor sales progress and action plans.
* Responsible for identifying patient pathways within the oncology offices in assigned territory and facilitating patient access to treatment.
* Promote assigned products to targeted oncologists and office staff, in-servicing all staff to ensure safe and appropriate drug administration, and work with all staff to make them aware of the suite of Gilead patient services
* Establish and develop business relationships with key customers, accounts, and relevant key opinion leaders.
* Experience in hospital and large account sales, managing through complex reimbursement issues.
* Strong written and verbal communication skills, solid presentation skills, and ability to influence others to represent Gilead at professional events and promote company products
* Partner with Medical Scientists, Marketing, and Market Access on various cross-functional projects to drive sales and patient adoption
* Demonstrates leadership among peers by consistent application and modeling of the appropriate compliance, behavior, and conduct
* Assist in the identification and resolution of issues and opportunities, communicate proactively to Marketing and Sales management.
* Complete necessary administrative tasks promptly, e.g., updating customer database, expenses, etc.
* Ensures all department personnel are fully informed of, and in compliance with Gilead commercial compliance policy, all applicable federal and state laws and guidance relating to product promotion and information dissemination including, but not limited to, the Federal Food, Drug, and Cosmetic Act, the Food and Drug Administration's implementing regulations, the Federal Anti-Kickback Statute, the False Claims Act, PhRMA, Corporate Code of Business Conduct and the Office of the Inspector General's Compliance Program Guidance for Pharmaceutical Manufacturers
Basic Qualifications:
* 6+ Years with BS/BA
OR
* 4+ Years with MS/MA
Preferred Qualifications:
* A valid drivers license is required
* A minimum of 7 years of pharmaceutical/healthcare sales experience and a BS/BA degree or equivalent, preferred.
* Previous product launch experience
* Possess superior selling skills in highly competitive markets
* Prior experience in oncology therapy.
* Prior experience in the therapeutic field of breast cancer is strongly preferred
* Aptitude for understanding scientific product related information.
* Strong interpersonal skills with the ability to lead and build working relationships internally and externally. Specifically, developing strong relationships with Oncology key opinion leaders.
* Proven expertise in influencing as well as strong negotiation skills
* Proven experience in account planning and cross-functional account management approach.
* Self-motivated and able to work with a general level of autonomy and independence.
* Familiar with industry trends and remain current with competitors' resources and practices.
* Demonstrated analytical skills, be able to identify and understand moderate to complex issues and problems and interpret information in a manner that provides appropriate recommendations to management and specialists.
* Strong ability to work in cross-functional teams
People Leader Accountabilities:
* Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the
way they manage their teams.
* Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current
performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and
realize their purpose.
* Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding
them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem
The salary range for this position is: $153,935.00 - $199,210.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
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* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For jobs in the United States:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.