Associate 2, Quality Control (QC) Viral Vector Analytical

Senior Associate,

Quality Control (QC) Viral Vector

General Description:

The

Senior

QC

Associate is

a member of the Quality Control team and is

responsible for providing

solid

technical leadership relative to the performance, validation, optimization, development, troubleshooting, and transfer of molecular biological, biochemical and chemical evaluations for drug substance, drug product. It is expected that

he/she

will work independently under minimal direction while

completing w ork assignments from semi-routine to complex in nature

delivering work product on time .

He/she is expected to provide strong cGMP knowledge and guidance to team members and will escalate issues as needed.

The

ability to recognize deviations from the accepted practice/SOPs

through foundational technical expertise and compliance is a requirement . Good written and verbal communication skills are essential.

Specific Responsibilities:

Lead efforts to p erform laboratory testing of BioMarin drug products and API's

Analyze, trend, and review quality control release and stability testing data of

BioMarin's

pharmaceutical products at Contract Testing Laboratories (CTLs) and/or Contract Manufacturing Organizations (CMOs)

Contribute to data review for several methods.

May have one or more direct reports and is expected to provide cGMP knowledge and guidance to QC team members.

Support activities for Pre-Licensing

Approval

Inspection (P A I ) readiness

Support

or lead

the preparation of phase-appropriate stability protocols and stability reports for API and drug product in accordance with regulatory requirements and as needed to support clinical trials and regulatory submissions

.

Lead

investigation s

conducted at CMO/CTL and review and approve out-of-specification (OOS) ,

out-of-trend (OOT)

and out-of-expectation (OOE)

testing results, deviations.

Support

or lead

the transfer of analytical methods to CTL's for

gene therapy

products. These methods may include HPLC, ELISA, and other methods .

Experience running and trouble-shooting cell-based methods is highly preferred.

S upport continu ous

improvement in quality systems (procedures and systems) to improve organization al

effectiveness, quality assurance compliance, and regulatory and other requirements (cGMP, ICH).

Work collaboratively with manufacturing/supply chain, quality assurance, regulatory, and project management to ensure timely availability of lot release, stability data, and other required analytical data.

Qualifications / Requirements:

Relevant experience in

a

Quality Control function

at an

Associate

level is required.

Ex perience in analytical development for biologics is required.

Experience with analytical systems (LIMS, laboratory control systems, stability/release systems) is

requir ed.

Functioned as audit support during previous inspections

is preferred .

Thorough understanding of regulatory agency (FDA) requirement and international guidance (ICH) for drug substance and product under GMP is required as applied to biologics .

Analytical development experience developing, qualifying, validating, and transfer of chromatographic methods (HPLC,

SE C , CZE ), spectroscopic methods

(FTIR. UV) , and other

physical and biochemical methods to analyze biologic or protein drug substances and drug products is required.

Demonstrated experience with development, qualification, and validation of ELISA or other immunoassays for potency, identity analysis for drug substance or product release is preferred.

Demonstrated experience with development, qualification, and validation of tests for identity, purity, potency for API and drug product (raw materials, in-process, release) and/or excipients is required.

Ability to effectively prioritize and deliver on tight timelines

in a fast-paced environment .

Excellent written and verbal communication skills.

Experience in analytical data systems (Empower, LIMS)

Accuracy and attention to detail.

Excellent cross-functional team participation skills.

Solid

problem-solving abilities.

Ability to be flexible with changing work needs

Interacts with other functional leaders, project management and QC/AD team personnel

Interacts with Contract Testing Laboratories, Contract Manufacturing Organizations, consultants and external partners

Functioned in a role with 1-3 direct reports

is preferred.

Education:

BS in

Molecular Biology, Genetics,

Chemistry, Biochemistry, Analytical Chemistry, or a related field

(with

5 - 8

years professional experience) .

MS in

Molecular Biology, Genetics,

Chemistry, Biochemistry, Analytical Chemistry, or a related field

(with

4 - 6

years professional experience) .

PhD in

Molecular Biology, Genetics,

Chemistry, Biochemistry, Analytical Chemistry, or a related field (with

2 - 3

years professional experience) .

~BIO