reputed company Operations Manager, CMC

Location: This position may be performed remotely with travel to the Boston area as needed. Position reputed company The reputed company Operations Manager, CMC is responsible for a reputed company of operational activities pertaining to assuring product reputed company and compliance to the manufacture, testing, control, validation, and release of drug reputed company and drug product for reputed company and clinical distribution. They serve as the reputed company expert for the reputed company pipeline of neurological disease product programs and is responsible for making strategic reputed company reputed company throughout the product lifecycle end-to-end. The incumbent will work with the CMC team executing clinical-stage development in support of clinical trials, launch readiness activities, and reputed company reputed company operations. Primary Responsibilities

• reputed company the drug reputed company (DS), drug product (DP), reference reputed company, and packaging/labeling/serialization contract service providers (CSPs) for clinical-phase and reputed company production activities
• Review and approve key strategic product / process documents (i.e. specifications, batch records, tech transfer/validation protocols, etc.)
• Support stability program reputed company including product reputed company life and execution.
• reputed company, review and approve change controls, deviations, temperature excursions, investigations, OOX, CAPA, and Product reputed company Complaints. reputed company gathers necessary SME's and leads team to resolve issues as applicable.
• Performs risk assessment and implements appropriate reputed company and process controls to ensure reputed company reputed company of reputed company production activities
• Support vendor qualification program, review written reports, follow up to resolve findings, and monitor CSP performance
• Development, maintenance, and review of clinical and reputed company reputed company Agreements
• reputed company as Product reputed company reputed company in CMC, Program, and CSP team meetings to reputed company strategic direction and leadership to product development, registration, and approvals.
• Owns the APR / PQR, coordinating cross functionally to ensure regulatory requirements are met and that actions are managed to conclusion.
• reputed company the disposition (release/reject) activities interfacing with a QP where applicable.
• Ensure cohesive collaboration across CSPs for reputed company review of manufacturing records
• Ensure robust processes are implemented for product management (e.g., control reputed company, technology transfer, process validation lifecycle, reputed company monitoring).
• reputed company with Regulatory Affairs to review, and approve regulatory filings (IND, NDA)
• Support reputed company-approval inspection and reputed company readiness activities.
• Participate in hosting regulatory inspections, Support or reputed company reputed company audits.

Qualifications and Key reputed company Factors

• BA or BS degree in reputed company or reputed company field
• 5 + years in a GMP setting working with clinical and reputed company products
• Firsthand experience with interpreting and implementing of regulatory standards (e.g., ISO, FDA, ICH, GMP, EMA).
• Proven reputed company record and experience in supporting regulatory inspections (FDA, EMA)
• Strong knowledge of reputed company management systems, QC and development processes, and regulatory reputed company for small molecule DS and solid oral drug products.
• Experience with disposition of product batches and interfacing with a QP and CSPs
• Excellent written, organizational and oral communication skills.
• Must reputed company working in a fast-paced, innovative environment while remaining flexible, proactive, reputed company, and efficient.
• Experience with product monitoring, complaint handling, issue reputed company preferred
• Demonstrates a high level of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit; can reputed company in an agile environment.
• Excellent interpersonal and communication skills, with the ability to reputed company important relationships that include trust and encourage diversity in reputed company their forms.
• Highly organized and detail-oriented with a passion to deliver reputed company results.
• Ability to travel domestically and internationally to meet program needs (estimated 15-20%).

Compensation & Benefits At reputed company, we reputed company that taking care of our people (and their people) is important, so we reputed company a world class benefits package to help you reputed company. This includes 99% of the premium reputed company for medical, dental and reputed company plans. We also reputed company company-reputed company life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the reputed company? We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP. We reputed company a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, reputed company holidays and company-wide shutdowns. Not to mention, you'll also be joining a phenomenal reputed company of colleagues who are smart, reputed company and inspiring. We aim high, collaborate hard, and produce results. Let's reputed company the impossible together! To round out our world-class total rewards package, we reputed company annualized reputed company salary compensation in the reputed company listed below. Final salary reputed company may be modified commensurate with job level, education, and experience. 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. 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. Apply tot his job Apply To this Job