Quality Control Manager

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:
Providing technical oversight to direct reports.
Ability to organize technical projects and manage multiple sub-projects.
Responsible for Reference Standard Program within the QC group.
Responsible for overseeing Cell Bank preparation/qualification, storage, tracking and ensuring adequate supply at all manufacturing sites at all times.
Provide training and support the direct reports as well as review data packages from contract manufacturing sites and updates the QC Associate Director.
Review QC related Raw Material documentations.
Work closely with the QA group to review data on time and to relate any Deviation or OOS results.
Work closely with the analytical development division to assure compliance and requirements of validation and transfer of methods to various off-site QC laboratories.
Responsible for QC representation in all method validation, qualification and technical transfer of test methods to contract manufacturing QC laboratories.
Write SOPs, review qualification and validation protocols and transfer reports.
Review data and identify any aberrant test results and investigate the root cause and establish CAPA plan.
Assist/ participate in establishing specifications for drug substance and products.
Audit and ensure GMP compliance of QC at contract manufacturing sites.
Assist in the development and maintenance of quality control systems.
Attends sub-team meetings for all drug candidates representing QC.
The position requires 20-30% travel to contract laboratories/ CMOs
Expectation to be in laboratory (if need arises) and to perform validation/test method transfers to various CMOs.
Train other members of the QC team in assisting with transfer reports.
Contribute to IND/ CMC preparation of QC documentation.
Participate and establish PAI readiness of QC documentations and training binders.
Participate in Agency audits.


Qualifications:
Minimum Requirements
Experience in supervising Reference Standard Program, Cell Bank and Raw Materials 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 developing, validating and trouble shooting analytical methods (HPLC-RP/IEX/SEC/Affinity, GC, Enzyme Activity Assay, CD, Spectroscopy, Electrophoresis) as applied to protein analysis.
Knowledgeable about the drug development cycle and participated in method development, qualification and transfer of in-process, release and stability of assays.
Excellent verbal and written communication skills.
Interpersonal skills and professional skills to interact with internal customers, vendors and contractors.


Desired Requirements:
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.
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.


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


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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