Sr Manager, QC

Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

This position is responsible for managing and coordinating the safety, quality, execution, and continuous improvement activities of the Quality Control Analytical (Bioassay, Biochemistry and HPLC) departments. This position ensures that all testing processes and departmental documentation meet Patheon - St. Louis and cGMP regulatory standards.

How will you make an impact?

As a people leader for the site, this individual will exhibit leadership traits and characteristics and be perceived by not only their group as a leader, but also by the site when Quality Control issues arise around the site. This will be accomplished by ensuring the following responsibilities are met, and by ensuring a strong Quality culture is maintained throughout the QC portions of the facility in cooperation with the aims and direction of the QC Director.

Coordinates, leads, and ensures the successful day-to-day operations of Quality Control departments for the company. The Sr. Manager ensures this success of the teams by oversight of the Managers (or possibly Managers and Supervisors) of the functional groups. Direct management of the individual contributors may occur on a limited basis as well.

Key Responsibilities:

• Hires, develops, and leads professionals within the Analytical Services department.

• Provides feedback and mentor, provides opportunities for growth and takes necessary disciplinary actions.

• Ensures awareness and compliance with Health authority regulations

• Coordinate/drive customer specific projects within functional area and assigns resources as appropriate. Works with customers to ensure clear and open communication is maintained.

• Responsible for the capacity forecast model for human and equipment resources and represents the Analytical Services organization at site / BU planning meetings

• Work with Quality Control Director and Quality Leadership to continually seek ways to improve the Quality Culture of the organization.

• Approves department budget and initiates cost control measures.

• Ensures adequate training (skills-based, cGMP and Safety) of personnel within department, to support various phases of production both clinical and commercial.

• Reviews departmental documentation (e.g., Standard Operating Procedures, STPs, and QBRs). Participates in revisions, providing input, as necessary.

• Provides departmental feedback to Quality Control Director.

• Report appropriate metrics to ensure timelines and turnaround time are on track

• Work with group leads to set milestone deliveries and ensure adherence to commitments

Minimum Requirements/Qualifications:

Education and Experience:

• Bachelor's degree Biologics or Chemical Sciences or equivalent
• 8+ years of experience in a regulated manufacturing, Quality or QC laboratory environment
• 5+ years prior supervisory or management experience required.

Knowledge, Skills, Abilities:

• Extensive knowledge and exposure to cGMP environment. Audit experience.

• Extensive knowledge of general and specific QC testing principles, as applicable to focus of position (e.g., chemistry, biochemistry, bio-assay, etc.).

• Knowledge of testing and associated equipment protocols and requirements and analytical instrumentation including biologic specific methodology.

• Strong interpersonal and communications skills; written and oral.

• Solid understanding of applicable regulatory requirements as it relates to analytical method transfer, USP, and stability

• Carries out duties in compliance with all local, state and federal regulations and guidelines including FDA, EPA, and OSHA

• Oversight of complex functional department, often including junior management levels

• Communicate effectively to peers and all levels of the organization within and outside of department. Interact with external contacts.

• Ability to work cross functionally with members of Quality Control, Operations, and Biologics Process Science (BPS) to meet timelines and objectives in a compliant manner

• Delegates and/or participates in Health Agency/internal audits.

• Provides overall departmental feedback to senior management.

Physical Requirements / Work Environment

• Be willing to wear a full gowning suit which includes: bodysuit, gloves, hair & beard nets, face covers, and safety glasses. (These items are prohibited: makeup, jewelry, nail polish, cologne / perfume, scented lotions or hair care products, etc.) Able to meet clean room gowning requirements, including wearing Tyvek, Nitrile, and/or Latex gloves

• Ability to lift minimum of 25 lbs independently

• Ability to stand for 80% of shift

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

We offer competitive salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement and a range of other employee benefits! We foster an exciting company culture that encourages innovation, forward-thinking, and an outstanding career and development prospects. Come be a part of the team!