Lead cGMP manufacturing activities for IA and biological formulations. Collaborate with cross-functional teams to achieve production goals and timelines. Review and approve batch records, change controls, and project plans. Develop, review, and approve SOP's and Work Instructions. Support investigations and drive root cause/corrective action culture. Coordinate manufacturing activities and supervise personnel. Promote a positive and proactive work environment to sustain strong employee eng... more details
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, No eye contacts allowed; prescriptive glasses will be provided, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
Thermo Fisher Scientific Inc. is seeking a highly motivated and experienced Manager, Formulations, IA & Biologicals to join our world-class team in Middletown, MD, USA. As the Formulation Manufacturing Manager, you will play a critical role in leading cGMP manufacturing activities for Immunoassays and Biologicals. You will be responsible for ensuring that our IA and biological formulations meet operational goals in safety, quality, delivery, and productivity. This is an exceptional opportunity to contribute to the development and manufacturing of materials for clinical trials and commercial use.
Excellent Benefits Package
Review our company’s Total Rewards
Medical, Dental, & Vision benefits-effective Day 1
Paid Time Off & Holidays
401K Company Match up to 6%
Tuition Reimbursement – eligible after 90 days!
Employee Referral Bonus
Employee Discount Program
Recognition Program
Charitable Gift Matching
Company Paid Parental Leave
Career Advancement Opportunities
Key Responsibilities:
- Lead cGMP manufacturing activities for IA and biological formulations
- Collaborate with cross-functional teams to achieve production goals and timelines
- Review and approve batch records, change controls, and project plans
- Develop, review, and approve SOP's and Work Instructions
- Support investigations and drive root cause/corrective action culture
- Coordinate manufacturing activities and supervise personnel
- Promote a positive and proactive work environment to sustain strong employee engagement levels
- Develop employees and provide feedback and coaching for performance improvement
- Drive innovation and continuous improvement activities to enhance compliance with quality procedures
- Other relevant responsibilities
Required experience and qualifications:
- Bachelor's or master's degree in biology, chemistry, life sciences, or a relevant field, or equivalent experience in a related role.
- Minimum of 10 years of formulation manufacturing experience, preferably in IVD, life sciences, cell culture, or pharmaceuticals
- Minimum of 3 years of people management experience
- Demonstrated ability to motivate employees and resolve conflicts
- Thorough knowledge of cGMPs
- Strong interpersonal and communication skills
- Ability to work in a fast-paced, dynamic environment
Thermo Fisher Scientific Inc. is an equal opportunity employer and provides reasonable accommodations for job seekers with disabilities. We value diversity and inclusion in our workforce, where diverse experiences, backgrounds, and perspectives are highly valued. Join our mission of enabling customers to make the world healthier, cleaner, and safer. Apply today at http://jobs.thermofisher.com.
Compensation and Benefits
The salary range estimated for this position based in Virginia is $93,800.00–$140,675.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards