Quality Control Testing Microbiology Lead

Bayer•Berkeley, CA

33d•$116,000 - $174,000

About The Position

At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice. Quality Control Testing Microbiology Lead Provides leadership, technical oversight and coaching to the QC microbiology organization responsible for sterility testing, viral testing, bioburden, endotoxin, and associated microbial testing.

Requirements

Bachelor's Degree in a science technical field or an equivalent combination of education and experience;
Experience in the biopharmaceutical or biotechnology industry
Leadership or supervisory experience;
Sound knowledge of sterility testing, viral testing, bioburden testing, endotoxin testing and related microbiological methods either through hands-on experience or oversight of team responsible for those methods;
Sound knowledge of cGMP and regulatory compliance (US and other international agencies) related to microbial testing of Biopharmaceutical products as related to scope of role;
Ability to support and prioritize many diverse activities simultaneously while meeting schedule commitments;
Strong leadership and interpersonal skills;
The ability to independently recognize opportunities and the need for business and process improvements and driving these improvements to completion. This must be linked with the ability to define and implement an optimal course of action in response to their recognition;
Experience with LIMS and other related computerized systems as well as knowledge with rapid technologies and automation for microbiological assays and techniques;
Experience in project management;
Effective Problem Solving;
Systematic and Quick Decision Making

Nice To Haves

10 plus years of experience in pharmaceutical/Biotech industry;
5 plus years leadership or supervisory experience;
Union experience

Responsibilities

Leads, coaches, and develops team providing support to the site for microbial testing, ensuring timely testing of associated samples and acts as system owner for electronic systems used in QC Microbiology;
Responsible for daily operations, scheduling, staffing, training, and troubleshooting to ensure all operations are in full compliance with applicable SOPs, safety guidelines and regulatory expectations;
Provides guidance and risk assessment for the resolution of discrepancies, OOS, unexpected results, lab investigations and Corrective and Preventative Actions (CAPAs);
Represents team at operational and cross-functional meetings, and routinely interacts with internal stakeholders, representatives from regulatory agencies, customers as well as internal auditors/inspectors;
Ensures conformance to all regulatory requirements, including those of the FDA and various international regulatory governmental bodies;
Interpret those regulatory agency requirements to coach and guide personnel as they respond to changing regulatory requirements;
Prepares and presents information, provides decision making support at meetings and disseminates information back to QC;
Creates, revises, and reviews documents of all types, including Standard Operating procedures (SOPs), written reports, investigations, technical reports, submissions to regulatory agencies, where applicable, and responses to regulatory comments, and validation protocols and reports;
Responsible for evaluating new technologies and requirements and implementing them as needed to stay current with best practices and new regulatory demands.