Associate Director, Quality Control (56861)

Job DetailsJob Location: Remote - Boston, MA 02110Position Type: Full TimeEducation Level: 4 Year DegreeTravel Percentage: Minimum of 2x/year to Boston areaJob Category: BiotechAssociate Director, Quality Control

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

 

Position Summary

Praxis is seeking a highly experienced, motivated, and innovative quality leader with strong experience in late-stage development and commercialization to join our Quality team as Associate Director, Quality Control to support QC product release and stability activities. Reporting to Senior Director, Quality Operations CMC, this position will be responsible for managing and executing Quality 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 methods, and in accordance with company’s and regulatory agencies’ policies and procedures.

 

Primary Responsibilities


Quality control oversight of contract lab activities e.g. routine testing, testing results review and approval, generation 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 lead clinical and commercial quality control compliance for stability, reference standard, and specification programs
Support the establishment of QC systems such as product specifications, product expiry, reference standard program, QC documentation including SOP’s, material specifications and other quality 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
Perform 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 generation, quality, and compliance review of bioanalytical data from preclinical and clinical projects for proprietary compounds and in some cases support for sample analysis projects
Support tox material inventory monitoring process, to ensure no impediments to completing studies
Additional responsibilities and ad hoc projects as required



Qualifications and Key Success Factors


Bachelors degree strongly preferred, with minimum of 6 years of experience in cGMP Quality Control environment
In-depth technical and regulatory understanding of GMP biologics manufacturing and testing including applicable international regulations/standards (GMP and ICH guidelines) in all phases of product development and commercialization
Experience managing third party assay laboratories, collaborations, and relevant bioanalytical vendors preferred
Extensive knowledge of GMP regulations, ICH guidelines, and stability testing requirements.
Proven track record of managing stability programs and COA processes for clinical and commercial products
Experience working in QC lab environment with hands-on experience in running, qualifying, and validating analytical methods
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 all levels of the business

Compensation & Benefits

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


99% premium cost covered for medical (Blue Cross Blue Shield), dental, and vision plans
Bonus program structured to pay on a quarterly basis
401k plan with 100% match up to 6% of employee’s contribution (Traditional & Roth)
Wellness benefit of $200/month towards incredibly flexible options including travel, fitness equipment & memberships, student loan repayment, sports fees and much more
Unlimited PTO, (2) weeklong shutdowns each 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 provide base salary compensation in the range of $150,000 to $169,000 annualized.  Final salary range may be modified commensurate with job level, education, and experience.

 


Company Overview 

Praxis Precision Medicines is a clinical-stage biopharmaceutica