Catalent Pharma Solutions Manufacturing Associate I in Harmans, Maryland
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 (http://www.catalent.com/index.php/about-us/Catalent-Careers2)
Manufacturing Associate I
The Manufacturing Associate is responsible for supporting the overall GMP upstream or 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.
This position will be located at our Harmans BWI location.
In concert with Catalent’s Patient First philosophy, this position is key in our efforts toward continuous improvement of our processes & information which will allow quality drug products to reach patients safely and efficiently.
The Role (daily responsibilities)
Completes Batch Production Records under cGMP, and documents in detail through the use of SOPs and BPRs for the processes and manufacturing steps
Generates operational protocol(s), internal or external documents including SOPs, BPRs, deviations and summary reports
May work with Process Development team and collaborate with Manufacturing Sciences and Technology group to transfer new projects into GMP
Generate and revise internal and external documents (SOPs, BRs)
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
Recommend equipment and other supply purchases within the production areas
Develop creative solutions to operational problems by leveraging knowledge of available theories and proven solutions
Work closely with production management for current and new manufacturing projects and help develop processes/techniques to meet contract objectives and avoid operational delays
Work closely with various departments and aid other teams as necessary
Interact with clients during initial and subsequent manufacturing campaigns; may be responsible to oversee and escort the person-in-plant (PIP) during manufacturing campaigns
Participate in facility expansion and equipment validation activities
Ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines
Leverages knowledge and application of the theories and principles utilized to solve operational, as well as routine tasks in the purification of proteins, antibodies, etc. for Phase I/II GMP manufacturing
Works closely with purification management to initiate new manufacturing projects and helps develop processes/techniques to meet contract objectives
Perform buffer preparations, in-process sampling, formulation of bulk drug substance
Conducts changeover and activation procedures for clean room suites and equipment
Submits in-process and cleaning samples to Quality Control with required documentation
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)
Leverages knowledge and application of the theories and principals utilized to solve operational, as well as routine tasks in the operation of microbial or cell culture processes (media/buffer prep, cell passaging, bioreactor production, harvesting operations)
Have excellent understanding and knowledge of mammalian, insect, viral and microbial processes
Experienced with suspension and adherent cell cultures
Experienced in using stainless and disposable single-use bioreactors (WAVE, Sartorius, Xcellerex)
Extensive experience in producing Master and Working banks (mammalian, insect, viral and microbial)
The Candidate (requirements)
- HS or GED with 4-7 years’ experience with upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance preferred
- Associate degree in a Scientific, Engineering or Biotech field with 2-4 years’ experience with upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance preferred
Bachelor’s degree in a Scientific, Engineering or Biotech field with 0-2 years’ experience with upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance preferred
Outstanding knowledge, and ability to apply scientific principles utilized to solve operational, as well as routine production tasks
Excellent documentation skills including comprehension, review & establishing Batch Production Records, SOP’s, deviation & summary reports
Catalent’s standard leadership competencies that are used to interview and for Performance & Development:
Leads with Integrity and Respect
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
Engages and Inspires
Coaches and Develops
Diverse, inclusive culture
401(k) retirement savings plan with company match
19 days’ Paid time off
Medical, dental, and vision insurance
Flexible spending account
Employee discount programs
Robust Employee Referral Program
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 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.
Catalent = Catalyst + Talent
Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!
personal initiative. dynamic pace. meaningful work.
Catalent is the perfect place to grow your career if…
You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).
You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world!
You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.
You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.
You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking (https://catalent.wd1.myworkdayjobs.com/External) for YOU!
See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here (https://www.youtube.com/playlist?list=PLuUGqEwwnH7hBwFlrsfSOH_raQHu4hOBK) .