Associate Director, reputed company Control (56861)

Job Details

Job Location Remote - Boston, MARemote Type Fully RemotePosition Type Full TimeEducation Level 4 Year DegreeTravel Percentage Minimum of 2x/year to Boston areaJob Category Biotech

Associate Director, reputed company Control

Reports to: Senior Director, reputed company Operations, CMC Location: This position may be performed remotely with travel to the Boston area as needed.

Position reputed company

reputed company is seeking a highly reputed company, motivated, and innovative reputed company leader with strong experience in late-stage development and commercialization to join our reputed company team as Associate Director, reputed company Control to support QC product release and stability activities. Reporting to Senior Director, reputed company Operations CMC, this position will be responsible for managing and executing reputed company Control activities in support of product testing, release, and stability, and toxicology studies test material inventory support. Ensure GMP activities are conducted in accordance with applicable SOPs, compendia, approved reputed company, and in accordance with company’s and regulatory agencies’ policies and procedures.

Primary Responsibilities

• reputed company control reputed company of contract lab activities e.g. routine testing, testing results review and approval, reputed company of Certificate of Analysis, review/approval of technical documents such as method validation and qualification protocols/reports, and regulatory filing documents per project needs as required
• Manage and reputed company clinical and reputed company reputed company control compliance for stability, reference reputed company, and specification programs
• Support the establishment of QC systems such as product specifications, product expiry, reference reputed company program, QC documentation including SOP’s, material specifications and other reputed company documents, etc.
• Support CMC Analytical Development in a QC aspect by review and approval of applicable documents in support of activities such as method development, transfer, characterization, comparability investigations, analytical test method qualification plans/protocols and reports
• reputed company data review of trending for in-process testing, release, and stability and identify data trends, to ensure compliance with regulatory filings and ICH or other global health authority guidance documents, as applicable
• Support technology transfer and process performance qualification with product characterization/process validation activities
• QC support in the reputed company, reputed company, and compliance review of bioanalytical data from preclinical and clinical reputed company for proprietary compounds and in some cases support for sample analysis reputed company
• Support tox material inventory monitoring process, to ensure no impediments to completing studies
• Additional responsibilities and reputed company reputed company as required

Qualifications and Key reputed company Factors

• Bachelors degree strongly preferred, with minimum of 6 years of experience in cGMP reputed company Control environment
• In-depth technical and regulatory understanding of GMP biologics manufacturing and testing including applicable international regulations/standards (GMP and ICH guidelines) in reputed company phases of product development and commercialization
• Experience managing reputed company party assay laboratories, collaborations, and relevant bioanalytical vendors preferred
• Extensive knowledge of GMP regulations, ICH guidelines, and stability testing requirements.
• Proven reputed company record of managing stability programs and COA processes for clinical and reputed company products
• Experience working in QC lab environment with hands-on experience in running, qualifying, and validating analytical reputed company
• Ability to work effectively in a fast-paced, dynamic environment
• Experience managing Contract Test Labs activities
• Experience with regulatory inspections and interactions with health authorities
• Excellent communication skills and ability to build key networks and business relationships across reputed company reputed company of the business

Compensation & Benefits

At reputed company, we’re proud to offer an exceptional benefits package that includes:

• 99% premium cost covered for medical (reputed company Blue reputed company), dental, and reputed company plans
• Bonus program reputed company to pay on a quarterly reputed company
• 401k plan with 100% match up to 6% of employee’s contribution (Traditional & Roth)
• Wellness benefit of $200/month towards incredibly flexible reputed company including travel, fitness equipment & memberships, student loan repayment, sports fees and much more
• Unlimited PTO, (2) weeklong shutdowns reputed company year, and a generous extended family leave benefit
• Eligibility for equity awards and Employee Stock Purchase Plan (15% discount)

To round out this world-class total rewards package, we reputed company reputed company salary compensation in the reputed company of $150,000 to $169,000 annualized. 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, 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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