Sr. Scientist, Downstream Process Development - Madison, WI | Biospace
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Sr. Scientist, Downstream Process Development

Catalent Pharma Solutions, Inc.

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Location:
Madison, WI
Posted Date:
9/26/2016
Position Type:
Full time
Job Code:
0018242
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Process Development, Senior Scientist,

Job Description

The Downstream Process Development team is responsible for the development and implementation of downstream processing methodologies and analytical procedures that can be easily transferred to the cGMP Manufacturing Team. Additionally, the Downstream Process Development team supports other groups including Cell Line Development and Upstream Process Development.

This position will perform a variety of laboratory procedures in Downstream Process Development. The position will perform daily work assignments accurately and in a timely and safe manner. The position will serve as a lead for technical advice and perform multiple complex projects at a time. This position is capable of working independently and without direction on assigned tasks/projects. This position plans and conducts work requiring independent judgment in the evaluation, selection, and substantial adaptation/modification of standard techniques, procedures and criteria. This position designs new approaches to problems encountered and uses a wide application of complex principles, theories and concepts in the specific field. This position works on complex problems of diverse scope where analysis of data requires in-depth evaluation of identifiable factors.

II. Specific Duties, Activities, and Responsibilities:
Initiates, directs and executes scientific research for innovation and process improvements

Acts as the technical lead for client development projects (including DOE), communicates project status internally and externally, and effectively provides technical explanation/rationalization

Researches and develops existing and new technologies/process improvements

Critically analyzes complex data, interprets and integrates experimental results with project objectives

Writes complex procedural SOPs, batch production records, and reports

Accurately reviews batch records and other data, ensuring consistency

Accurately ships purified samples to clients and fills out appropriate paperwork

Executes purification experiments including automated chromatography (AKTA platform), filtration, clarification, column packing, and tangential flow filtration independently

Expert knowledge of protein purification and analysis with an in depth understanding of all modes of chromatography

Maintains documentation of experiments and/or batch records according to good documentation practices

Demonstrates expertise knowledge of scale up principles with respect to purification and filtration

Demonstrates experience with viral clearance validation and scale down models for biopharmaceutical processes, including review and interpretation of results

Leads technology transfer of processes to a cGMP facility

Participates in quality control and quality control tracking systems including change control and deviations

Manages daily lab operations including oversight of 5S audits, stocking consumables, lab organization and cleanliness, and safety

Manages interaction with CRO facilities and vendors that support process development and manufacturing projects

Contributes to maintenance of visual control board including tracking metrics, safety updates, and leading daily meetings in absence of director

Updates group members on background and status of client projects by giving oral updates or internal presentations

Aligns best practices and new technologies with needs of process development and manufacturing departments

Maintains project timelines

Troubleshoots and problem solves in order to initiate and execute/monitor corrective actions

Performs general lab housekeeping, including cleaning/sterilizing of lab and lab materials, disposal of trash and recyclables, autoclaving, ordering and stocking supplies, etc.

Accurately completes routine and preventative maintenance on laboratory equipment

Actively participates in team meetings

Prepares buffers as necessary

Mentors others, as assigned

Performs lab overview for client tours and internal clients (shadowing)

Other duties as assigned

Requirements

Ph.D. in Biotechnology, or related field with at least 7 years of laboratory experience, preferably in an industrial setting

MS in Biotechnology or related field with at least 10 years of industry laboratory experience

B.S/B.A. in Biotechnology, or related field with at least 12 years of industry laboratory experience

Experience:
Aseptic technique experience

Process scale chromatography and filtration (viral, chromatography, tangential flow, normal flow) experience

Viral clearance validation, scale up, and technology transfer

Operating, maintaining, and troubleshooting chromatography work stations and process skids preferably in an industrial setting

Knowledge and experience working in a cGMP environment

Good documentation practices (GDP)

Experience writing standard operating procedures, batch records, and reports

Experience mentoring junior staff regarding laboratory procedures and scientific projects

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. Catalent is headquartered in Somerset, N.J. For more information, visit 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 to Jobs@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.