Technical Manager, QA CMO Small Molecule - Novato, CA | Biospace
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Technical Manager, QA CMO Small Molecule

BioMarin Pharmaceutical Inc.

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Location:
Novato, CA
Posted Date:
9/19/2017
Position Type:
Full time
Job Code:
13408
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Description
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.

SUMMARY

This position is responsible for managing Quality Assurance lot release activities and responsibilities regarding the technical review and disposition of drug substance (DS), Drug Product (DP), and Final Product manufactured at BioMarin's Contract Manufacturing Organizations.  This position manages the review and approval of manufacturing Batch Records and Certificates of Analysis and the issuance of Certificates of Compliance.  This position ensures that the contract manufacturing SOPs and batch records are in compliance with cGMPs, and identifies and assists in the correction of areas of cGMP deficiency, such as deviations.  This position also serves as the technical quality reviewer and approver for deviations, change records, CAPAs, etc. generated form or pertaining to Contract Manufacturing.  This position interacts with CMO, Quality Control, Regulatory Affairs, Planning and Supply Chain.

RESPONSIBILITIES

Perform technical review of quality events (deviations, change requests, supplier notifications, etc) as documented by contract manufacturers and BioMarin contract manufacturing operations departments.

Provide QA decision/direction/leadership in assigned interdepartmental meetings.

Understand regulatory/validation requirements assessed for changes and the implications for lot disposition (holds, proceed at risk, etc).

Manage and coordinate batch record review of all contract manufacturing and ensure staff review executed batch records in compliance with cGMPs and BioMarin SOPs.

Ensure proposed events are adequately supported and technically sound, in consultation with internal colleagues form various departments (e.g., contract manufacturing operations, validation, QC).

Manage lot release activities, and the communication of lot release schedules.

Represent QA to other key personnel within Contract Manufacturing, Materials Management, Quality Control, Planning and Regulatory Affairs.

Leverages experience in chemical manufacturing processes (drug substance and/or drug product) and operations to ensure that BioMarin Quality standards are met during external manufacturing operations.

Customarily and regularly exercises discretion and independent judgement in the performance of the duties described above.

Other duties as assigned.

Requirements

EXPERIENCE

Required Skills:

8 or more years of experience in pharmaceutical manufacturing or Quality, or MS with 5 or more years of experience in pharmaceutical manufacturing or Quality, preferably with 3 or more years of experience in pharmaceutical quality assurance role.

Must have some prior hands-on experience in interacting with CMO (API and/or DP) in cGMP environment.

Applicable expertise should include drug substance and/or drug product processes:

Drug substance experience would include work in small molecule, peptide, and/or oligonucleotide chemistry
Drug product experience would include solid dosage or parenteral forms
Experience with typical unit operations in drug substance and/or drug product manufacturing is required; applicable experience would include batch reactors, drying equipment, chromatography, lyophilization, spray drying, and aseptic fill/finish
Experience with analytical methods commonly used in chemical manufacturing processes, including RP-HPLC, GC, NMR, MS, Elemental Analysis, LOD, KF, and particle size distribution.

Desired Skills:

8 or more years of experience in pharmaceutical manufacturing or Quality, or MS with 5 or more years of experience in pharmaceutical manufacturing or Quality
Planning, prioritizing, and goal setting skills.

Decision making and problem solving with technical expertise in API and DP.

Skilled in participative management with technical knowledge, builds overlap of personal/team goals, and enthusiastically works with others.

Willingness to travel to CMOs (domestic and international) as needed (approx. 10%) and meetings with external Quality counterparts.  Note that some off-hours work may be required due to time zone differences with off-shore CMOs.

Background in small molecule synthesis and sachet manufacturing highly preferred.

ASQ CQE is a plus

EDUCATION

Bachelor of Science degree in Chemistry, Chemical Engineering, Biochemistry or related technical field

EQUIPMENT

Computer, Printer, Scanner

CONTACTS

This individual interacts with Quality Assurance, CMO Manufacturing, Quality Control, Materials Management, Planning and Regulatory Affairs personnel at BioMarin and external CMO.

SUPERVISOR RESPONSIBILITY

None  ~BIO