Scientist, Upstream Process Development (Tech Transfer) - Madison, WI | Biospace
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Scientist, Upstream Process Development (Tech Transfer)

Catalent Pharma Solutions, Inc.

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Location:
Madison, WI
Posted Date:
6/23/2017
Position Type:
Full time
Job Code:
R901598
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Process Development, Scientist,

Job Description


The Technical Operations (TO) team is responsible for the knowledge and physical transfer of internal and external processes from the development environment to the GMP manufacturing group. For the upstream representative, unit operations to be transferred include, but are not limited to scale-up, SUB parameter and inoculation specifications, specific parameter monitoring and data collection, media and feeding strategy and harvest criteria.

This position will be expected to have a working / hands on knowledge of the processes required to support both Upstream Process Development and Manufacturing. The position will perform work assignments accurately and in a timely and safe manner. The position will serve as a lead for technical advice for scalability of processes for the development group, manufacturing fit and as the subject matter expert to support the process once the initial transfer has been completed. It is expected, that a person filling this position is capable of working independently and without direction on assigned projects. This position identifies plans and conducts work requiring independent judgment in the scalability and transfer of robust upstream processes to a GMP setting.

Specific Duties, Activities, and Responsibilities:

This position will interface with both process development and manufacturing groups for the successful transfer and scale-up of upstream processes. The duties are divided into three main categories: Development (pre-clinical), Tech Transfer, and GMP (clinical). Further detail is listed below.

Development:

* Preparation and review of engineering/toxicology BPRs for the upstream process based on an internally developed process
* Preparation and review of engineering/toxicology BPRs for the upstream process based on an externally transferred process. Requires significant customer interaction.
* Identification of critical consumables interfacing with Catalent’s supply chain and procurement groups as well as vendors.
* Support and shadowing for the execution of engineering/toxicology batches with the longer term of goal of oversight and execution of these batches.
* Review of executed engineering/toxicology BPRs including the compilation of process recommendations and process changes.

Tech Transfer:

* Preparation of process flow diagrams, scale documents and process transfer summary for each transferred project
* Coordinate with manufacturing lead to share information and support implementation of process
* Identify gaps between process development and manufacturing and align best practices
* Organize kickoff/ transfer meeting (s) with manufacturing and process development
* Support manufacturing lead for process scale changes after initial transfer.
* Close out meetings with manufacturing and process development to review lessons learned and best practices

GMP:

* Generation of new part numbers for critical and non-critical process components
* Ordering of critical consumables and long lead time items for GMP production
* Preparation and review of GMP BPRs for the upstream process based on engineering/toxicology batch including recommendations and approved process changes.
* Support GMP execution of transferred process in the GMP suites as subject matter expert. Requires GMP training
* Other duties as assigned

Requirements


Education:

* PhD in Biotechnology, or related field, with no prior experience; or
* M.S./M.A. in Biotechnology, or related field, with minimum of 4 years’ experience in related laboratory work; or
* B.S./B.A. in Biotechnology, or related field, with minimum of 7 years’ experience in related laboratory work.

Experience:

* Aseptic technique experience
* Upstream process development experience in large scale bioreactors, preferably Single Use Bioreactors
* Writing batch production records and technology transfer documents
* Operating, maintaining, and troubleshooting large scale bioreactors in an industrial setting
* Knowledge and experience working in a cGMP environment
* Good documentation practices (GDP)
* Experience writing standard operating procedures and reports
* Experience mentoring junior staff regarding laboratory procedures

About Catalent

Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products.  With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. For more information, visit http://www.catalent.com/

More products. Better treatments. Reliably supplied.™

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 toJobs@catalent.com. 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.

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