Associate Principal Scientist, Downstream, Biologics Process Development and Commercialization
- Kenilworth, NJ
Our company, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its legacy for over a century. Our company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Our Manufacturing Division, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of biologics, vaccines, pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
As part of our Manufacturing Division, within the Manufacturing System Design & Commercialization, the Biologics Process Development & Commercialization department provides the technical process leadership and laboratory capabilities in support of late stage pipeline and commercial manufacturing processes for biologics (therapeutic proteins). For pipeline programs, this team supports various commercialization activities, including technology transfer to internal and external manufacturing sites, process validation, and authoring of regulatory submissions.
- Participates in and/or leads cross-divisional technical teams focusing on late stage clinical process development, characterization, and technology transfer and validation with line-of-sight for licensure and commercialization.
- Responsible for laboratory-scale and manufacturing scale studies to support commercial process validation, characterization, and investigation evaluations, including studies performed either in-house or externally. Provides technical leadership for the design of experiments, data analysis and interpretation, as well as mentoring of junior staff in the execution of internal or management of external laboratory activities.
- Provides technical leadership in the interpretations of trends observed in commercial process monitoring (e.g., statistical process control (SPC) and/or multivariate analyses (MVA)), and for further technical investigations and process changes that seek to drive improvements to yield and/or robustness
- Primary focus will be on downstream processing, but with a working knowledge of the various aspects of product manufacture and functional area interdependencies, including cell culture, analytical, and site readiness.
- Position will interact with and influence various functions across the late stage development and commercialization ( i.e., process development, analytical, quality, technical operations, external manufacturing, regulatory, value chain management). Position will also lead functional area on cross-functional and cross-divisional teams and may manage a small team of scientists/engineers.
- Authors required regulatory and technical documentation. Ensures that process/product are developed and documented according to standard company practices.
Education Minimum Requirement:
- BS, MS or PhD in Chemical Engineering/Biochemical Engineering/Chemistry/Biochemistry/Biological Engineering/Biological Science with 10 years (for BS), 8 years (for MS), or 4 years (PhD) relevant experience.
Required Experience and Skills**:
- Technical expertise in purification of biological molecules, including laboratory models for chromatography and filtration systems.
- Experience with technology transfer and scale-up of processes to pilot and manufacturing scales for biologics manufacture.
- Excellent oral and written communication skills. Ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies, etc, in a multi-disciplinary team environment.
Preferred Experience and Skills:
- Experience with downstream purification of biological molecules required, with an in-depth knowledge of preparative chromatography, tangential flow filtration, and virus retaining filtration desired. Demonstrated understanding of the fundamentals and/or modeling of unit operations is a plus.
- Technical operations experience in the manufacture of biological molecules at the pilot- and/or commercial-scale is a plus.
- Prior experience in late stage process development, process characterization including viral clearance studies, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory BLA sections and/or working with external contract organization for development and or manufacturing.
- Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software)
- Working knowledge of statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) techniques for biologics processes.
- Working understanding of analytical methods to characterize biologics and /or US/EU regulatory requirements and / or working knowledge of cGMPs is a plus
Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that's committed to delivering a high quality, reliable supply to customers and patients on time, every time.
Our Company., Inc., Kenilworth, New Jersey, USA is known as "Our Company" in the United States, Canada & Puerto Rico. We are known as "Our Company" in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world's biggest investors in Research & Development.
What we look for ...
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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