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Purification Manufacturing Consultant
311 Pennington-Rocky Hill Road Pennington, NJ 08534 US
Job Description
General Description:
The Purification Manufacturing Technician I / II position will directly enable the initial start-up phase of the Hopewell manufacturing facility and then shift focus to hands-on execution and support of cGMP manufacturing operations.
1) Facility Start-Up: Focused on cell culture related activities required to design, build, commission, and license the company's first biopharmaceutical plant in the United States.
Essential functions of the job include but not limited to:
A. Design review
B. Equipment selection, procurement and testing
C. Protocol development and exeution
D. Acceptance testing and equipment/automation debugging
E. Technical training
2) Hands-On cGMPOperations: Focused on execution of cGMP manufacturing activities required to deliver the production plan reliably and compliantly.
Essential functions of the job include but not limited to:
A) Follow cGMP procedures to support manufacturing execution and automated recipes.
B) Clean-In-Place (CIP) & Steam-In-Place (SIP).
C) Buffer preparation & transfers / filtration
D) Operational and cleaning of chromatography and filtration systems.
E) Equipment & process troubleshooting.
F) Deviation identification, reporting and closure.
G) cGMP procedure development and optimization.
Additional Skills/Attributes Required:
? Evidence of good verbal and written communication.
? Ability to work in fast paced dynamic environment with competing priorities.
? Demonstrated ability to collaborate within and between diverse groups.
? Proactive identification and implementation of continuous improvement opportunities.
? Able to receive and incorporate feedback – passion for ongoing professional development a plus.
? Aptitude for learning moderately complex technical systems.
Physical Requirements:
? Must be able to stand for long periods, up to 8 to 12 hours/day.
? Must be able to reach above shoulder level, bend/stoop, push/pull, and handle/grip frequently.
? Must be able to work scheduled 40 hours with the ability to work overtime as needed.
? Must be comfortable in working in varying temperatures.
? Frequent lifting, pushing, pulling, and carrying. Ability to lift to 40 lbs.
? Regular reaching, bending, stooping, and twisting.
? Repetitive motion and substantial movement of the wrists, hands, and/or fingers.
? Environment requires dedicated gowns, depending on area.
? Work with hazardous materials and chemicals.
? Willing to work any shift.
Education Required:
High school education or GED required - OR - AS/BS/BA in science related field, biopharmaceutical or equivalent technical experience preferred.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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