Senior/Associate, Contract Manufacturing

Altus Pharmaceuticals, Inc.

Location: Waltham, Massachusetts 02451
Posted on: 10/22/2008 1:32:08 PM
Postion type: Full time
Job Code: 1395518HHL
Required Education: Bachelor's Degree
Salary: Competitive

DESCRIPTION
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.
Assist the Managers of the Contract Manufacturing team with the following:

- Evaluation and selection of DP CMOs to support Altus clinical and commercial material requirements.
- Coordination of external CMOs towards successful execution of technical and manufacturing campaigns. May involve with direct management of an external CMO contract.
- Development of models for capacity, supply, and cost of goods.
- Coordinating technology transfer of products from research & development to CMOs
- Assist Manager in supporting process characterization and scale up of process and managing engineering and validation runs at CMO for drug product.
- Assist Supply Chain Logistics staff with scheduling and planning for all clinical, development and toxicology manufacturing campaigns at CMOs.
- Help to ensure that all clinical and non-clinical study material needs are met through coordination of external CMO activities. Help to ensure that material supply needs are met to support internal development efforts and pharmacological studies.
- Aid in review of master and executed batch records. Assist in generation, review, and revision of manufacturing related SOPs.
- Manage and track data for each manufacturing campaign including process, QA and QC activities.
- Coordinate with internal teams to keep track of activities and act as a liaison for the CMO
- Responsible for providing segments of person-in-plant coverage during manufacturing at CMO.
- International and domestic travel to external CMOs as required.
- To qualify for this opportunity you should have a B.S .or B.A. degree in a science or chemical or biotechnology engineering field along with 2-5 yrs. of experience in biopharmaceuticals industry, manufacturing experience preferred.
- Some knowledge of cGMP systems is required. Ability to work in a technical team environment and evidence of successful cross-departmental interactions are essential.
- Previous work in a matrix management system valuable.
- Excellent written and verbal communication skills are required.
- Excellent organizational skills.
- Previous experience with external contract manufacturing organizations is a plus especially in solid dose manufacturing.
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.

Altus Pharmaceuticals is an equal opportunity employer.

REQUIREMENTS:
See Job Description Label