Associate Director, Quality Control

Job Description
Job Description:


Qualification & Experience:

PhD or MS in Biochemistry/Biotechnology or related subject area. Minimum 5 years of experience with a proven track record in QC of protein therapeutics. Strong leadership skills in directing a highly trained scientific team to meet ONS objectives.

Job Description:

This position will directly report to the VP of Development Sciences with the responsibilities including (but not limited to):

Lead QC group in qualification and validation of analytical methods for clinical protein therapeutics (50%)

Establish a talented functional group of 3-5 or more staff.

Setup lab & equipment to establish the labs.

Oversee the transfer and qualification of methods; guide stage-appropriate method validation with hands on experience.

Work closely with Analytical and Formulation Sciences to ensure successful implementation of developed methods. Guide the group to focus on established and new art science and technology to meet project needs.

Publish and patent scientific work and present work in leading international conferences.
Support Quality functions in GMP manufacturing (40%)

Provide infrastructure for quality testing of in-process, lot release, and stability testing for Oncobiologics clinical manufacturing projects.

Address QC/GMP issues of biologic products. Work closely and support Analytical, Formulation and Process Development on QC/GMP issues, including OOS results and NC/CAPA resolution.
Evaluate CRO/CMO labs; coordinate and manage the outsourcing of specific methods, including those for environmental monitoring and raw materials testing

Culture (10%)


Support business development activities as required.

Support solutions for innovation and collaboration.

Develop customer relationships with peers.

View DescriptionJob Title: Senior Scientist/Engineer – Purification Development

Job Description:


Qualifications: PhD/MS/BS in Biochemistry, Chemistry, Chemical Engineering or equivalent

Experience:Minimum 5+ years of experience in absence of graduate degree, 2+ years if MS, or entry level PhD; must have demonstrated ability to design and evaluate experiments; must utilize statistical design of experiments and be flexible in executing and responding to changes in scheduling, along with innovating solutions in a transparent team environment; must have strong focus on creativity and continuous improvement. Strong knowledge of both preparative and analytical chromatography required.

Job Description:

This position will report to the Head of Purification Development with the responsibilities including (but not limited to):

A. Purification Development (50%)

Represent purification development in team meetings as required.

Develop purification platform process and associated analytical in-process analytical through the application of design of experiment for rapid speed to First in Human Studies.

Implement state of the art science and technology for screening chromatography resins and other separation techniques including automated liquid handling systems.

Collaborate with other functions to deliver an efficient low cost solution to customers.

Execute and design experiments while maintaining a current laboratory notebook with
scientific rigor to meet project needs for process development.

Evaluate Protein-A, Ion Exchange, Hydrophobic Interaction chromatography resins and other separation techniques for rapid process development and protein separation modeling.

Develop scalable chromatography methods that minimize types of buffers and maximize efficiency of operations in manufacturing.

Have core competency in filtration including methods for cell culture/fermentation clarification, tangential flow filtration and viral clearance.

Execute process development enabling analytics required to make development decisions rapidly. Should have experience with HPLC/UPLC, electrophoretic, ELISA and SPR technologies and equipment.

B. Equipment and Facilities (30%)

Participate in starting up facility and process equipment. Work to deliver state of the art technologies specifically around liquid handling systems for high-throughput process development.

Develop efficient and innovative solutions to enable multi-host development and cGMP facility design and operation.

Follow full GMP guidance and fulfill all regulatory requirements where necessary.

Operate safely and according to company environmental requirements.


C. Culture (20%)

Evaluate technologies and propose ideas for innovation.

Support business development activities as required.

Present data or ideas in team meetings.

Follow all company best practices to minimize cost and meet budgetary requirements.

Head of Purification Development may assign other responsibilities as required.

Location: Cranbury, New Jersey (map)

Company

Oncobiologics, Inc.

Job Code

State or Province

New Jersey

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