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Company

Original Job Post

Amgen · 1 week ago

Process Development Sr Principal Scientist

Cambridge, MA

Full-time

Hybrid

Senior Level

7+ years exp

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BiotechnologyHealth Care

H1B Sponsorship

Actively Hiring

Comp. & Benefits

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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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Pharmaceutical industry experienceBiotech industry experienceProcess developmentProduct developmentAnalytical method developmentSmall molecule analysisStructure elucidationSolid-state characterizationOrganic chemistry knowledgeMethod validationMethod transferSynthetic small moleculesPeptide method developmentOligonucleotide method developmentAnalytical control strategyAnalytical methodologiesLCGCMSUVKFNMRFTIRGLP requirementsGMP requirementsTechnical transferContract organizations managementCMC teams guidanceNon-clinical teams guidanceQuality Target Product Profile

Required

Bachelor’s degree and 8 years of scientific experience OR

Master’s 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

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

Amgen

Glassdoor

4.2

Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.

Founded in 1980

Thousand Oaks, California, USA

10,001+ employees

http://www.amgen.com

H1B Sponsorship

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Distribution of Different Job Fields Receiving Sponsorship

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2023 (349)

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