Manager, QA Compliance

Altus® is focused on developing and commercializing novel protein therapeutics for patients with chronic gastrointestinal and metabolic diseases. Altus' in-depth knowledge of protein crystallization has resulted in a proprietary pipeline of orally-delivered and injectable protein replacement products. As a company, we are committed to improving the quality of life of patients.

Our success is a result of our ability to recruit and retain highly qualified and motivated people who are among the best in the industry. Located in the heart of the biotechnology industry, Altus is only steps from two of the world's premier scientific research institutions and within miles of some of the country's leading hospitals and physicians. We seek to leverage this location to attract some of the best and brightest individuals in the field and foster innovation in a fun and exciting entrepreneurial setting.

Primary Duties & Responsibilities:
The role of the Quality Control Manager consists of advanced responsibilities including:


Manage Stability Program for multiple products at multiple sites (pre-initiation, initiation, duration and post-study activities).

Providing technical oversight to direct reports to review stability data packages.

Assist with proper GMP procedures in place for sample pull and inventory tracking.

Ensure the receipt of data in timely manner to compile internal binders.

Verify all data from the stability studies reviewed by direct reports and conduct trend analysis.

Investigates and resolves OOS, OOT and atypical stability results.

Writes CMC stability sections of Annual Reports, and IND amendments.

Generate interim stability reports for all lots.

Development, Implementation and maintenance of protocols/procedures/individual Master Stability Plan for all products.

Maintain stability database (initiation of link data portal).

Evaluates trends and reports stability data for internal use and for FDA via required periodic reports.

Ability to organize all stability projects with timeline and ensure compliance at all sites.

Set-up GMP Stability Studies for Phase I-III clinical trails per ICH guidelines.

Works closely with the payroll to ensure budgeted activities are on track.

Provide required training to subordinates.

Periodic onsite audits of various CMOs to ensure processes are being followed.

Present current stability data at CMC meetings.

Effective communication with inter-department and external CMOs to ensure all aspects of study are carried out per timelines.

Attends sub-team meetings for all drug candidates representing QC.

The position requires 20-30% travel to contract laboratories/ CMOs

Participate and establish PAI readiness of QC documentations and training binders.

Participate in Agency audits.



Minimum Requirements


Experience in supervising Stability Program is essential to this position.

Interacting with Agency Representatives (both FDA and EMEA) during audit procedure is valuable to establish the PAI readiness.

Strong background in analytical methods as applied to protein analysis.

Knowledgeable about the drug development and experience in interacting with process development, QA and RA is essential in order to support drug product specification based on stability data.

Experience working with contract laboratories and contract manufacturing organizations.

The person in this position is expected to function with no day-to-day supervision on routine job duties; a review of new assignments with direction from the area supervisor is expected.

An understanding of the concepts and systems applied to QC tests and GMP operations is expected.

Desired Requirements


Ability to understand, diagnose and troubleshoot assays and instruments and to offer solutions at the contract manufacturing sites.

Experience in working in a fast paced team based environment is critical for success.

Ability to work independently and to make decisions based on experience.

Excellent verbal and written communication skills.

Interpersonal skills and professional skills to interact with internal customers, vendors and contractors.

Education:
MS in Chemistry or a biological science with 4-6 years of relevant experience or a BSc. with 5-8 years experience in QC and a minimum of 3 years of supervisory experience. Additional requirement of 2-4 years of data and documents review experience.


CLOSING
Altus Pharmaceuticals is an equal opportunity employer.

Note To Recruitment Agencies:

Altus Pharmaceuticals does not accept unsolicited resumes from any agencies or individuals that offer candidates for a fee. Any recruiter or agency seeking to work with Altus Pharmaceuticals must contact human resources at careers@altus.com and enter into a signed fee agreement. Resumes submitted to Altus hiring managers or employees without consent will be deemed the property of Altus Pharmaceuticals Inc.


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