Associate Supervisor, cGMP Upstream Biomanufacturing (Sun – Wed, 6am – 4pm) – Offering $1,000 Sign on Bonus

Associate Supervisor, cGMP Upstream Biomanufacturing

Offering $1,000 Sign on Bonus

Days and Shift: Sun – Wed, 6am – 4pm

The Shift Lead, cGMP Biomanufacturing – Staging is the shift lead role for the solution preparation group supporting the weighing of raw materials and staging of equipment. This position requires a variety of skills necessary for a cGMP Biomanufacturing environment. Independently perform Biomanufacturing operations, while adhering to SOPs and working in a cGMP compliant environment. Analyze and interpret results in written and oral format. Other duties will include Batch Production Record/data review, drafting technical documents protocols and reports, training/mentorship of (including contributions to performance management) staff and driving process improvement initiatives. The role will also ensure that staff continues to be developed to keep pace with department goals and growth. This position generally leads five to ten operators. The Shift Lead spends the majority of the time assigning, reviewing, checking work, assisting in the manufacturing suites and eliminating ordinary difficulties. The position is expected to follow detailed instructions and established procedures with minimal supervision.

This is a permanent, full time Salaried position, Sunday – Wednesday 6am – 4pm

Our new, state of the art Madison, WI facility, with expanded mammalian cell line engineering and biomanufacturing capabilities utilizing single-use systems, offers increased flexibility and manufacturing scale to support our customers’ growth. We offer a broad range of integrated formulation and analytical services to solve your most difficult development challenges in Biologics.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

The Role:

• Lead cGMP Biomanufacturing activities
• Author and revise Standard Operating Procedures (SOP), Batch Production Records (BPR) and Job Aid (JA)
• Maintain effectiveness of Quality system
• Performs Daily review and final sign-off of executed cGMP documentation (BPRs, forms)
• Lead general cleanroom housekeeping, including room and equipment cleaning(s), disposal of trash and recyclables, and adherence to 5S standards
• Proven leadership abilities: ability to oversee junior staff involvement with deviations and ability to mentor operators regarding regulatory requirements
• Ability to transfer knowledge to others via training or mentoring of direct reports; ability to guide others through communication and learning
• Ability to interpret and apply Technology Transfer Reports into BioManufacturing

The Candidate:

• M.S./M.A. in Biotechnology, or related field, with minimum of 3 years’ experience in related work or related experience with demonstrated career progression including leadership responsibilities
• B.S./B.A. in Biotechnology, or related field, with minimum of 5 years’ experience in related work or related experience with demonstrated career progression including leadership responsibilities
• Associates Degree, minimum of 6 years’ experience in in related laboratory work or related experience with demonstrated career progression including leadership responsibilities or equivalent experience

Experience:

• Required
  • Clean room, aseptic technique, and/or general lab equipment experience
  • cGMP, Good documentation practices (GDP), Good Laboratory Practices (GLP) knowledge
  • Following standard operating procedures
  • Experience operating, maintaining and troubleshooting Biomanufacturing-related equipment
• Preferred:
  • Lead/Supervisor experience
  • Experience with SUBs
  • Experience with Trackwise, ComplianceWire or other electronic tracking software

Why you should join Catalent:

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• 19 days of paid time off annually + 8 paid holidays
• Competitive salary with yearly bonus potential
• Community engagement and green initiatives
• Generous 401K match and Paid Time Off accrual
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement
• On-site fitness center and wellness programs

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.