Great Pharma company in Irvine - benefits are attractive, and a commitment to work-life balance
This Jobot Job is hosted by: Michael Montevideo
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Salary: $80,000 - $100,000 per yearA bit about us:
We are your single source for high-quality chemistry, manufacturing and control (CMC) services for the pharma, biotech, and medical device industries. Our comprehensive suite of services streamlines processes to accelerate time-to-market. With more than 30 years' experience, we have deep scientific expertise across a range of products, with a special focus on oligonucleotides.Why join us?
You'll partner with the thinkers who have laid the foundation for next-generation therapies and the doers who are changing the world. You'll work in a diverse, respectful, and safe environment where our teams are empowered to create wonders. The work is rewarding, the benefits are attractive, and our commitment to work-life balance is refreshing.Job Details
Supervise and contribute to the Microbiology Department's daily operations in support of aseptic manufacturing, ensuring adherence to project schedules, cGMP requirements, company policies and procedures.
- Supervise a team of multiple analysts simultaneously handling a of microbiology samples and assigning tasks, checking work at frequent intervals, and maintaining schedules based upon directives from senior management. May become actively involved with hands on work, as required, to meet schedules and resolve problems.
- Provide senior level expertise to junior level staff on day-to-day Microbiology EM operations supporting aseptic manufacturing as well as identify or troubleshoot issues that may affect laboratory or facility monitoring systems or processes.
- Review all EM data generated and draft EM trend reports, monthly and quarterly EM reports for management review.
- Support, train and qualify all EM technicians, analyst and MFG associates.
- Provide technical support in the maintenance of monitoring systems and instrumentation.
- Schedule and maintain communication with manufacturing, maintenance, engineering and validations in order to complete all required environmental and utility monitoring per internal procedural requirements with minimal impact to interdepartmental schedules.
- Represent department in operational meetings and regulatory audits.
- Prepare, approve and/or read and understand test methodologies, study protocols, reports and Standard Operating Procedures in order to review or execute testing in compliance with necessary cGMP policies and procedures. Record/review data in controlled notebooks, data sheets, and electronic systems (i.e. LIMS, etc.) in accordance with cGMP requirements.
- Notify supervisor of any discrepancy in laboratory testing or general laboratory operations. In case of any observed discrepancies, initiate and follow through with the required quality exception documentation as needed.
- Inventory management for the Micro group to support manufacturing work as well as in lab testing.
- Support the development and growth of the department by performing advanced level duties, like conducting independent research to collect necessary information from available literature, performing complex analyses and critically analyzing data with minimal guidance, training and mentoring less experienced staff with regards to best laboratory practices, techniques, and troubleshooting method and equipment related issues.
- Make recommendations to management with regards to potential business opportunities and/or process improvements.
- Provide feedback to employee and management regarding noteworthy employee performance, make recommendations for employee coaching and counseling and advancement where applicable.
- Mentor, motivate and challenge to drive high performance and develop team members, encouraging them to reach their full potential.
- Oversee workplace cleanliness by implementing, managing and monitoring the 5S method of organization.
- Promote a culture of safety, whereby all accidents are preventable, and support site safety initiatives.
- This list of duties and responsibilities is not all inclusive and may be expanded to include other duties and responsibilities, as management may deem necessary.
- In order to meet business needs, weekend and after hour work is required to meet deadlines.
Qualifications - Experience and Education:
- A minimum of 4 years, 6+ years preferred, Pharma MFG EM and USP testing related work experience.
- Bachelor's degree or equivalent in scientific discipline required.
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