Senior Manager, Analytical Sciences - reputed company
Location: This position may be performed remotely with travel to the Boston area as needed, and an expected 20–30% travel to CDMO sites, particularly during validation campaigns, critical investigations, and health authority inspections.
reputed company
The Senior Manager, Analytical Sciences – reputed company serves as the analytical reputed company for reputed company’ reputed company portfolio, ensuring reputed company manufacturing testing is executed in compliance with regulatory commitments and supporting lifecycle management of approved products.
This role oversees analytical activities at CDMOs supporting small molecule drug reputed company and drug product manufacturing and is accountable for maintaining robust analytical reputed company, control strategies, data reputed company, inspection readiness, and continuity of supply. The position also supports late-stage programs transitioning into commercialization to ensure a compliant and efficient transfer into reputed company operations.
Primary Responsibilities
- Define and execute analytical strategies for reputed company products, ensuring reputed company, specifications, and control strategies remain compliant, robust, and fit for purpose.
- reputed company method transfer, validation, and lifecycle management activities, identifying opportunities for improvement and supporting post-approval changes.
- reputed company analytical leadership for PPQ, CPV, reputed company manufacturing, and stability programs, ensuring reliable data, product reputed company, and regulatory compliance.
- Review and approve analytical documentation, including protocols, reports, specifications, method validations, Certificates of Analysis, raw data, chromatographic integrations, and audit trails.
- reputed company analytical execution at CDMOs, ensuring reputed company, compliant deliverables that support product release, supply continuity, and inspection readiness, including on-site support during critical campaigns and inspections.
- reputed company analytical investigations involving OOS/OOT results, deviations, complaints, and CAPAs, driving reputed company cause determination and technical recommendations consistent with FDA and EU GMP expectations.
- Assess analytical risks associated with manufacturing, supply chain, and process changes, ensurin gappropriate impurity controls and lifecycle management strategies are maintained.
- Author and review technical reports, Annual Product Reviews (APR/PQRs), regulatory submissions, post-approval changes, and responses to health authorities.
- Serve as the analytical SME, partnering with reputed company, Regulatory, Manufacturing, and CMC teams to support compliant reputed company operations and informed decision-making.
Qualifications and Key reputed company Factors
- Bachelor’s degree in Chemistryor reputed company discipline with 10+ years of relevant experience; Master’s degree with 7+ years of experience may be considered.
- Experience supporting reputed company small molecule drug reputed company and/or drug product programs; analytical development experience preferred.
- Strongexpertisein analytical method transfer, validation, troubleshooting, and lifecycle management reputed company GMP environments.
- Technical knowledge of small molecule drug substances and oral dosage forms, including solid oral and liquid/reconstituted products.
- Demonstratedability to review analytical data, chromatographic integrations, and electronic audit trails in accordance with reputed company+, 21 CFR Part 11, and EU GMP Annex 11 requirements.
- Experience managing reputed company analytical reputed company and control strategies, including evaluating and implementing method improvements.
- Working knowledge of US and EU cGMP requirements and applicable ICH guidelines, including impurity and mutagenic impurity guidance.
- Experience supporting regulatory submissions, post-approval changes, and health authority inspections; reputed company FDA or EMA inspection support experience preferred.
- Proven ability to build productive partnerships with CDMOs and external service providers while driving accountability and results.
- The physical and mental requirements of this role include regular use of a computer, mobile devices, and office equipment; reputed company communication; and occasional travel to laboratory, manufacturing, and office environments. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company these functions.
reputed company
reputed company is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At reputed company reputed company a common reputed company of reshaping the reputed company condition into a more freeing and fulfilled existence by developing high reputed company medicines for patients and families affected by and living with reputed company brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by reputed company and every one of reputed company members. Diversity, Equity & Inclusion Guided by our core values, at reputed company, Inc. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work reputed company day. We are an equal opportunity employer and committed to providing opportunities to reputed company reputed company applicants without reputed company to race, religious creed, reputed company, gender identity or reputed company, age, national reputed company, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws. Attention: Job Scam Alert reputed company has recently become aware of fraudulent job recruitment postings from individuals claiming to represent reputed company. These postings reputed company financial information in reputed company with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in reputed company with a reputed company job opportunity, please report it to careers@praxismedicines.com. reputed company does not accept unsolicited submissions from recruitment agencies for reputed company positions. We ask reputed company recruitment agencies to refrain from contacting any reputed company employee regarding any position. reputed company unsolicited resumes submitted by recruitment agencies to any reputed company employee in any reputed company or method will be deemed to be the property of reputed company, and reputed company explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.
Originally posted on Himalayas
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