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 8 years of formulation manufacturing experience with Bachelor's or 6 years with advanced degree (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.