Job DescriptionPosition 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 herePosition Summary The cGMP Biomanufacturing group is responsible for current Good Manufacturing Practices (cGMP) production activities, including Master/Working Cell Bank production, Upstream cell culture, Downstream protein/mRNA purification, and/or Fill/Finish. The Specialist, cGMP Upstream Biomanufacturing requires a variety of skills necessary for a cGMP Biomanufacturing environment. S/he will 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 position is expected to follow detailed instructions and established procedures with minimal supervision.Work hours: Sunday - Wednesday 7:00 am - 5:30 pmThe Role+ Leads cGMP Biomanufacturing production activities, including daily review of executed cGMP documentation and communication with clients+ 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).+ 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.+ Monitors and mentors team members on Biomanufacturing activities.+ Supports continuous process improvement initiatives. ?Upstream/Cell Banking+ Operate Biomanufacturing equipment, such as, incubators, bioreactors (SUB), filtration equipment and controlled-rate freezers+ Perform small and large scale cell culture production of mammalian cell lines, such as cell counting, cell passaging, culture metabolite analysis+ Cell cryopreservation activitiesThe Candidate Education:+ PhD in Biotechnology, or related field, with a typical minimum of 2 years' experience; or+ M.S./M.A. in Biotechnology, or related field, with a typical minimum of 3 years' experience; or+ B.S./B.A. in Biotechnology, or related field, with a typical minimum of 5 years' experience in related laboratory work; or+ Associates Degree/Certificate/Diploma in Biotechnology, or related field with a typical minimum of 6 years' experience+ High School Diploma or equivalent with a typical minimum of 7 years' experience in related laboratory work.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:+ Experience with SUBs, SUMs, Unicorn and/or Delta V software(s)+ Experience with Trackwise, Compliancewire or other electronic tracking softwareCatalent's leadership competencies+ Leads with Integrity and Respect+ Delivers Results+ Demonstrates Business Acumen+ Fosters Collaboration and Teamwork+ Champions Change+ Engages and Inspires+ Coaches and DevelopsPosition 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 processCatalent 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 ~~~/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 ~~~. 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 + TalentYour 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 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. 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 ~~~. 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.