BioSpace · 1 week ago
Process Development Sr Principal Scientist
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Responsibilities
Lead and mentor a group of analysts in supporting process development. Provide career development guidance to the team members.
Lead an Attribute Sciences team to support synthetic small molecule, synthetic peptide, and/or SiRNA drug substance and drug product process development, manufacturing, release & stability testing and characterization.
Collaborate closely with drug substance and drug product process development colleagues to achieve project objectives.
Define analytical control strategies and implement methodologies for development of late phase clinical programs.
Thorough understanding of cGMP/ICH regulations, compendial requirements related to analytical method development and comprehensive control strategy development.
Provide concise summary to cross-functional leadership for endorsement of key decisions.
Oversee activities at contract manufacturing and testing sites.
Author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents. Address analytical and product quality inquiries from health authorities.
Qualification
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Required
Bachelors degree and 8 years of scientific experience OR
Masters degree and 6 years of scientific experience OR
Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] and 3 years of scientific experience
Preferred
PhD in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Material Sciences, Pharmaceutical Sciences, or related discipline.
7+ years experience in the pharmaceutical or biotech industry, focusing on process and product development and analytical method development for synthetic drug substances and products.
Strong understanding of small molecule analysis, structure elucidation and solid-state characterization informed by knowledge of organic chemistry.
Hands on experience in method development, validation, and transfer for in-process, release, and stability testing
Strong experience in synthetic small molecules, peptide or oligonucleotide method development, characterization, and analytical control strategy.
Advanced technical expertise in analytical methodologies for process development and product characterization of synthetic products including LC, GC, MS, UV, KF, NMR, FTIR et al.
Solid understanding of GLP and GMP requirements and their application in a phase appropriate manner
Experience in technical transfer for non-GMP and GMP production and testing to external contract organizations, able to manage deliverables against timelines.
Excellent communication skills and ability to provide concise summary to cross-functional leadership and guidance to CMC and non-clinical teams, e.g. informing and defending the Quality Target Product Profile
Ability to work effectively in cross-functional teams, and across various geographic locations in different time zones.
Excellent technical writing skills with attention to detail in authoring methods, specifications, technical reports, and regulatory filing documents
Benefits
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
Company
BioSpace
BioSpace is the leading online community for industry news and careers for life science professionals.
Funding
Current Stage
Growth StageTotal Funding
$10M2000-08-24Series B· $10M
Recent News
2024-05-31
2024-05-05
2024-04-06
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