Upstream Mfg Scientist

Upstream Manufacturing Scientist ? Gainesville, FL area
Kelly Scientific is seeking an experienced biologics manufacturing scientist in the Gainesville, FL area. This is a direct hire opportunity. Monday ? Friday on the 1st shift.
Ideal candidates will have experience with viral vector manufacturing in a FDA and GMP regulated environment. Experience with protein purification is highly preferred.
Relocation may be provided.
Position Description/Summary:
The Scientist position will support cGMP manufacturing activities to ensure that the company provides clients with investigational materials for pre-clinical and clinical use.? This position will perform hands on cGMP production of Master Cell Banks (MCB), Master Viral Banks (MVB), recombinant protein and viral vectors under the supervision of the Upstream Manufacturing Manager.? Will work with the Upstream Manufacturing Manager to trouble-shoot technical problems.? Will also review executed records related to production activities, write or review deviations, investigations, etc. related to cGMP production.? Will be expected to prepare and modify documents (SOPs, PBRs, RMSs, qualification protocols, etc) required for cGMP production, to maintain the equipment in the upstream production suites and to order equipment and oversee its installation and qualification. Will also work closely with Facilities, Quality Assurance, and Quality Control units to achieve production goals and timelines.? Will also be expected as available to perform experiments in process development leading to transfer of same to production.? This includes technical review and interpretation of data produced by self and others; preparation of experiments/data for presentation, participation in laboratory investigations, and the organization of experiment and production results for reports.
Essential Responsibilities:
Production (25%)

  • Assist organizing and coordinating upstream manufacturing activity efforts in production suites

  • Execute hands-on cGMP manufacturing with other team members and follow detailed protocols, PBRs and SOPs, to complete production runs in an efficient, safe and correct manner. Conduct production suite changeover and prepare and/or request necessary components and raw materials, labels, etc. to successfully execute production batch records

Prepare and Review Documents (25%)

  • Write process procedures including PDPRs, SOPs, PBRs, RMS and qualification protocols, etc for new processes or equipment. Assist in the execution and review of IQ, OQ and PQ protocols and summary reports.

  • Write Change Controls, Planned Variances, Deviations and Investigation Reports etc.

  • Review executed Production Batch Records (PBR), and other production related documents

Assist the Upstream Manufacturing Manager in; (20%)

  • Assist in the development or optimization of upstream processes for manufacturing

  • Coordinate and assist in the technical transfer of processes from clients and/or process development to manufacturing.

  • Assist in organizing personnel for the efficient completion of production runs

  • Search and source cGMP compatible equipment and raw materials.

Module Readiness (20%)
Assist to ensure that upstream manufacturing modules operate efficiently and meet timelines and schedules through performing required calibration, cleaning, equipment preventative maintenance as required by SOP and the review of material inventory
Communication (5%)

  • Assist in the communication between departments on a day to day basis.

  • Communicate to manager immediately any deviations or challenges that may or may not have product impact for efficient resolution.

  • Daily two-way communication between the manager and supervisor to discuss daily and weekly goals

Other Duties as
?Assigned (5%)
Knowledge, Skill, and Requirements:
A bachelor's degree in an appropriate area of specialization (molecular biology, virology, biochemistry, immunology) and one year of appropriate experience in same or related fields.? Appropriate college coursework may substitute at an equivalent rate for the required experience.
Preferred Qualifications:
Master?s and one year of work experience in the fields of virology, molecular biology, biochemistry, and /or cell biology.
Hands on experience in cell culture (small and large scale), transfection, infections, rAAV production by transfection and by using baculovirus systems. An in-depth understanding of upstream and good knowledge of downstream processing methods. Experience in a cGMP production and testing environment. Excellent communication skills including technical writing.
Work Hours:?? Typically, Monday through Friday, 8:00 A.M. ? 5:00 P.M.
Requires availability to work early in the morning, in the evenings, holidays, weekends and overtime when required to meet timelines. These hours would be mandatory

Why Kelly??

With Kelly, you?ll have access to some of the world?s highest-regarded scientific organizations?
providing you with opportunities to work on today?s most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits you?ll be proud to help
advance. We work with 95 of the Fortune 100? companies, and found opportunities for more than 9,000
scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a better place. Let Kelly fuel your career?connect with us today.

Kelly Services?

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect
with us on Facebook, LinkedIn and Twitter.

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.


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