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Job Description

Job Title: Downstream Processing Supervisor (Band 6)

Location/Division Specific Information

St. Louis, MO/ Drug Substance Division (Biologics)

Discover Impactful Work:

• The supervisor is accountable for the success and oversight of downstream manufacturing processes. This means being responsible for the carrying out a variety of functions related to Downstream Biopharmaceutical Manufacturing. These functions may include but are not limited to activities such as conducting large scale chromatography, viral inactivation, viral filtration, ultrafiltration and diafiltration, as well as aseptic filling of bulk drug substance.

A day in the Life:

• Execution of manufacturing batch records, work instructions and/or SOPs, with minimal instruction on a day-to-day basis and a focus on proactive ‘right the first time’ executions. Assist with batch record reconciliation.

• Able to complete all Department functions, such as maintaining suite, supplies, equipment, logbooks and data in accordance with site SOPs and policies.

• Documentation of all activities to meet cGMP requirements. Daily record review, tasks, and databases.

• Forecast and resolve supply and raw material deficiencies. Identify and resolve scheduling conflicts with one week outlook.

• Identify deviations, aid in investigations/root cause analysis, and provide input on major/critical deviations.

• Represent manufacturing team at tier meetings.

• Practices and promotes safe work habits and adheres to safety procedures and guidelines.

• Utilizes manufacturing process knowledge and investigational skills to identify and resolve manufacturing issues and drive continuous improvement in process operations.

• Provides feedback on document revisions and/or document management including batch production records and manufacturing procedures.

• Maintain safe and clean work environment by educating and directing personnel to ensure compliance with established policies and procedures.

• Coordinates training with team either in class or on the floor, as needed.

• Helps build cross-functional relationships and enhances relationships with team members.

• Provides frequent feedback and coaching to others on ways to improve performance.

• Complete production plan by scheduling and assigning personnel, prioritizing tasks, supervising progress, revising schedules, resolving problems, and reporting results.

• Lead shift exchanges and daily huddles for team as required. Act as liaison with other groups within the manufacturing organization and a Subject Matter Expert on various techniques.

Keys to Success:

Education:

• HS Diploma/ GED required, Bachelor's degree preferred

Experience:

• 5 - 9 years relevant work experience required based on education

• 2+ years supervisory/leadership experience preferred (pharmaceutical industry preferred)

• Experience in cGMP environment preferred

Knowledge, Skills, Abilities

Knowledge

• Knowledge of cGMP practices, aseptic techniques, or chemical concepts- preferred

Skills

• Strong math skills

• Critical thinking and problem-solving capabilities

• Detail Oriented

• Results Driven

• Efficient in MS Office

Abilities

• Critical evaluation of processes, including foresight and thinking ahead.

• Able to read, write, and communicate in English

• Able to understand and carry out instructions

• Reliable

• Effectively multi-task

• Able to work in an environment of change

• Able to work independently and as part of a team

• Able to recognize problems developing, not just occurring

• Seeks and welcomes feedback and responds to coaching.

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 adhere to 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

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) . As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

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

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

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.