Team Lead, Manufacturing - Downstream
Catalent
 Harmans, MD

Job Description

Position Overview:

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here

Team Leader, Downstream Manufacturing

Position Summary

The Team Leader, Downstream Manufacturing is responsible for supporting the overall GMP downstream manufacturing process, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of bulk biologics from microbial and cell culture systems for Phase I/II & commercial GMP manufacturing.

The Role

  • Acts as team or shift lead with indirect supervisory responsibilities for a group of Manufacturing Associates and responsible for training of new employees or existing team members
  • Completes Batch Production Records under cGMP, and documents in detail through the use of SOPs and BPRs for the processes and manufacturing steps
  • Support initiation and closure of deviations; may serve as the lead in the departmental investigation and be responsible for closing out deviations and CAPAs
  • Troubleshoot process and equipment problems; Work with Facilities and Validation to maintain manufacturing equipment
  • Work closely with production management for current and new manufacturing projects and help develop processes/techniques to meet contract objectives and avoid operational delays
  • Interact with clients during initial and subsequent manufacturing campaigns; may be responsible to oversee and escort the person-in-plant (PIP) during manufacturing campaigns

The Candidate

  • HS or GED with 7-10 years' experience with downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance OR Associate degree in a Scientific, Engineering or Biotech field with 4-7 years' experience with downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance OR Bachelor's degree in a Scientific, Engineering or Biotech field with 3-5 years' experience with (column chromatography, buffer/media skid) biologic production processes under GMP compliance
  • 1 or more years leadership experience such as team or project management
  • Excellent documentation skills including comprehension, review & establishing Batch Production Records, SOP's, deviation & summary reports
  • Has excellent understanding and knowledge of isolating and purifying proteins from microbial and cell culture processes
  • Extensive experience with chromatography equipment, columns, TFF, CIP procedures and of processes to purify bulk proteins, antibodies, etc. (HIC, IEX, Affinity)
  • Lifting to 40 lbs., unassisted may be required at times.
  • Shift work and/or weekend work is required at times.

Must possess 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

  • Medical, Dental, Vision and 401K are all offered from day one of employment
  • 19 days of paid time off annually
  • Potential for career growth within an expanding team
  • Defined career path and annual performance review and feedback process

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.

personal initiative. dynamic pace. meaningful work.

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, 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.