Scientist 2 / Sr. Scientist 1, QC Viral Vectors Analytical (Gene Therapy), Technical Operations

Location
Novato, CA, United States
Posted
Sep 17, 2019
Ref
21600
Required Education
Bachelors Degree
Position Type
Full time
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients' lives.

General Description:

The

Senior

Scientist 1/2

QC

is

a member of the Quality Control team and is

responsible for providing

solid

technical leadership

and guidance

relative to the performance, validation, optimization, development, troubleshooting, and transfer of molecular biological, biochemical and chemical evaluations for drug substance, drug product.

He/she should exhibit strong cGMP knowledge and guidance for junior team members

and escalate issues as needed .

It is expected that

he/she

may

lead/manage

two

or more

reports

independently while

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

and delivering work product in a timely manner .

Demonstrated ability to work in a cross-functional setting is a requirement.

The

ability to recognize deviations from the accepted practice/SOPs

through foundational technical expertise and compliance is a requirement .

Strong technical knowledge, cGMP knowledge, and leadership skills are a requirement.

Good written and verbal communication skills are essential.

Demonstrated ability to work effectively in a quality control testing environment

and work with external contract testing labs (CTLs)

are requirements for the position.

Specific Responsibilities:

Lead /manage

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

May manage

two

or more direct reports.

Contribute to data review for several methods.

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) .

Lead

activities for Pre-Licensing

Approval

Inspection (PL I ) readiness .

Support/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.

Lead

the transfer of analytical methods to CTL's for

gene

therapy

based

products

and lead/support method optimization and trouble-shooting as needed . These methods may include HPLC, ELISA,

cell-based potency

and other methods .

Champion

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

managing and testing as a leader in a

Quality Control function

at a

S cientist

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

and/or lead audit support

during previous inspections.

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,

optimization,

qualification, and validation of ELISA or other immunoassays for potency, identity analysis for drug substance or product release is

required .

Demonstrated experience with development,

optimization,

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 .

Previous experience

in a lead role with

3 - 6

direct reports

is required.

Education:

BS in

Molecular Biology, Genetics,

Chemistry, Biochemistry, Analytical Chemistry, or a related field

(with

10 - 14

years professional experience) .

MS in

Molecular Biology, Genetics,

Chemistry, Biochemistry, Analytical Chemistry, or a related field

(with

6 - 10

ye ars professional experience) .

PhD in

Molecular Biology, Genetics,

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

4 - 8

years professional experience) .

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. ~BIO