Seeking 1 Process Development Scientist Location: 100% Remote Description: Position drives the Process Development activities for an E.
coli expressed recombinant protein and will also provide oversight to contract manufacturing, product testing, and overall GMP production.
Position oversees and ensures full compliance with applicable GMP regulations.
Drive the development / optimization of E.
Coli expressed recombinant protein manufacturing from downstream fermentation to upstream purification to support upcoming Clinical Trial.
Design methodical and detailed experiments to develop and optimize recombinant protein manufacturing process, with risk / benefit assessed at each step.
Oversee manufacturing of clinical material.
Lead the evaluation of any issues related to manufacturing (deviations, non-conformances), which includes root cause analysis, CAPA implementation, and GMP compliant Change Control documentation.
Partner with Quality to ensure a quality and compliant manufacturing environment.
Draft, review, and/or approve quality related documentation, which includes raw material specifications, component specifications, batch records, deviation reports, Change Control documentation, validation protocols/reports and CAPA plans.
Skills: process development, GMP, recombinant proteins, batch record, pharmaceutical, protein purification, process optimization, drug development, raw material Additional Skills & Qualifications: Minimum Masters degree in science field preferred; Bachelors considered with extensive relevant experience.
Minimum 5 years experience in E.
Coli expressed recombinant protein process development and optimization.
Minimum 2 years experience in GMP manufacturing of E.
Coli expressed recombinant protein.
Experience Level: Expert Level ___________________________________________________________________________________________________________________________________________________________________________ Compensation is tied to the Colorado market for jobs performed in Colorado.Other locations may be subject to variances basedon locations-related factors.
We reserve the right to pay above or below the posted wagebased on factors unrelated to sex, race, or any other protected classification.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment.
Benefits aresubject to change and may be subject to specific elections, plan, or programterms.This temporary role may be eligible for the following: Medical,dental & vision 401(k)/Roth Insurance(Basic/Supplemental Life & AD&D) Shortand long-term disability Health& Dependent Care Spending Accounts (HSA & DCFSA) Transportationbenefits EmployeeAssistance Program TimeOff/Leave (PTO, Vacation or Sick Leave) About Actalent: Actalent connects passion with purpose.
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