Catalent Pharma Solutions Lead, cGMP Biomanufacturing in Madison, Wisconsin

Job Description

Lead, cGMP Biomanufacturing

Position Summary

Catalent has a Lead, cGMP Biomanufacturing position available that will report directly to the Manager, cGMP Biomanufacturing. The Lead cGMP Biomanufacturing role manages the technology transfer process (both Internal and External) into Manufacturing. This position will act as the Subject Matter Expert (SME) on Biomanufacturing activities and oversee the implementation of operational process improvements and process excellence in collaboration with internal and external stakeholders, ensuring respective requirements are met and integrated in the Manufacturing process.

In concert with Catalent's Patient First philosophy the identified position is critical to delivery of better biologic therapies to patients. Dedication to exceed patients expectations begins with the integrity an individual shows in their role. Only by placing patients as the primary focus of our work, do we ensure the safety, reliable supply, and optimal performance of our products.

The Role

  • Actively manages resolution of deviations, out of specifications and CAPA’s, including via cross-functional teams.

  • Leads and develops others’ training in process and compliance-related procedures to ensure regulatory requirements and company policies are met.

  • Supports the validation and execution of process equipment to meet timelines and regulatory requirements.

  • Operates and troubleshoots cGMP Biomanufacturing equipment such as pH/conductivity meters, mixing tanks (SUMs), tubing fusers/sealers, filter integrity testers, peristaltic pumps, balances and Biosafety Cabinets (BSC) or Laminar Flow Hoods (LFH). Maintains effectiveness of Quality system.

  • Routinely drafts and revises Standard Operating Procedures (SOP), Batch Production Records (BPR) and Job Aids (JA)Leads deviation investigations and change control/protocol execution within established timelines.

The Candidate

  • PhD in Biotechnology, or related field, with minimum of 3 years’ experience in related laboratory work; or M.S./M.A. in Biotechnology, or related field, with minimum of 5 years’ experience in related laboratory work; or B.S./B.A. in Biotechnology, or related field, with minimum of 7 years’ experience in related laboratory work; or Associate’s in Biotechnology, or related field, with minimum of 9 years’ experience in related laboratory work.

Experience:

  • Clean room, aseptic technique, and/or general lab equipment experience.

  • cGMP, Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) knowledge.

  • Experience with SUBs, SUMs, Unicorn and/or Delta V software(s). Experience with Trackwise, Compliancewire or other electronic tracking software.

Catalent’s standard leadership competencies that are used to interview and for Performance & Development:

  • Leads with Integrity and Respect

  • Delivers Results

  • Demonstrates Business Acumen

  • Fosters Collaboration and Teamwork

  • Champions Change

  • Engages and Inspires

  • Coaches and Develops

Position Benefits

  • Competitive base salary with other compensation incentives

  • Medical, Dental, Vision, and 401k are all offered on day one of employment

  • 19 days of Paid Time Off (PTO) + 7 paid holidays

  • Defined career path and annual performance review and feedback process

  • Volunteer time paid off (we believe in giving back to our community!)

  • Onsite gym, tuition reimbursement, discount corporate perks and other benefits too numerous to list!

About Catalent

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. More products. Better treatments. Reliably supplied. ™Visit www.catalent.com/careers to explore career opportunities.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a 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.

Catalent offers rewarding opportunities to further your career – join the global drug development and delivery leader! You will help develop some of the nearly 200 products we launch each year or help supply some of the over 7,000 products for patients around the world. Our highly skilled, dedicated global team of over 9,500 is passionate about improving the health of patients by combining their personal expertise with advanced technologies to advance science and supply innovative new products of the highest quality to patients globally.

Why Catalent?

  • Gain unparalleled experience by working on multiple products and technologies – we launch nearly 200 new products for our customers each year.

  • We have 20 global pharmaceutical Product Development teams on five continents, who are, at any given time, working on over 700 new products and hundreds of ongoing clinical trials.

  • Our products include some of the latest life-saving medicines as well as some of the most well-known consumer health brands used by families every day.

  • Catalent’s more than 30 global facilities on 5 continents manufacture over 70 billion doses of over 7,000 important medicines and consumer health products.

  • Nearly 1 in 20 doses of medicines taken around the world has been touched by the Catalent team.

  • We have +1,100 patents on many superior patient-preferred technologies used by all the top pharmaceutical, biologic and consumer health companies.

  • We established the Catalent Applied Drug Delivery Institute to drive collaboration and scientific exchange among industry professionals, academics and partners.

  • Many of our 1,400+ scientists are regularly published in top industry journals and present at top industry conferences to advance knowledge sharing and the development of better life-saving medicines.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.