Argonaut Manufacturing Services, Inc. is a contract manufacturer of life science reagent consumables and Biopharmaceutical drug products. The company offers cGMP manufacturing with CFR21 Part 820, 210, and 211 compliance.
With the advances in genetic and biomarker analysis, new applications emerge daily to efficiently answer important biological questions of both scientific and industrial relevance. Argonaut is an independent external manufacturing service (CMO) company dedicated to serving these highly innovative companies. Argonaut is a high-quality provider of cost-effective solutions and services.
Position and Scope
The purpose of this position is to assist with the organization and execution of production flow as well as documentation of production results for our manufacturing teams in a GMP level facility. This is a hands-on position, which will require supporting the team in day-to-day activities, ensuring training compliance, and seeing that batch records are completed on time and error-free. The individual will also support continuous improvements within the manufacturing team and support process qualifications. We are looking for an energetic, hands-on, knowledgeable problem solver who can assist with the implementation of new filling/finishing labs, SOPs, and laboratory equipment as necessary to complete client projects. Strong time management and organizational skills along with interpersonal skills are needed for this exciting opportunity to help create a highly efficient manufacturing team.
The successful candidate will:
- Possess strong communication skills and the ability to work with and lead cross-functional teams under strict timelines
- Have excellent problem solving / troubleshooting skills and the ability to analyze and interpret data to make business-critical decisions
- Be able to execute validation experiments
- Manage the following Quality system compliance while working in a cGMP and ISO13485 production environment
- Pay attention to detail and be disciplined in execution
- Have strong initiative and willingness to take ownership and drive projects to completion
- Hire and provide mentorship and training to manufacturing team members, and provide technical guidance and leadership, as necessary
- Have the ability to work independently and also in a team-based environment
- Create and revise manufacturing documentation, processing documents, SOPs, manufacturing pilot plans, etc.
- Serve as a subject matter expert for manufacturing during varied audits by customers and regulatory bodies
- Advise the leadership team of factors that may affect the quality of the product, initiate problem reports for deviations and non-conforming materials, and provide guidance/options and ideas for corrective actions and preventive actions (CAPA)
- Have knowledge of Aseptic techniques and how to apply them in the manufacturing process
- Have a working knowledge of lab equipment
- Have experience working with liquid handlers, plating platforms, labeling equipment, and sealing equipment
Position Requirements and Experience
The desired candidate will have:
- Hands-on experience in molecular biology (5 years) with proven skills of high-throughput filling processes handling DNA, RNA, sequencing, microarray products
- Proven knowledge in process validation
- Excellent written and verbal communication skills
- Ability to communicate effectively with people in other disciplines
- Knowledge in lab space layout and design from a Lean Manufacturing perspective
- Experience following standard operating procedures and recording data extemporaneously in batch documentation while following good documentation practices
- Good documentation practices
- BS in Molecular Biology, Biochemistry, BBA in Supply Chain Management, and 2+ years of experience in an industrial environment (manufacturing or R&D) with focus on molecular biology or 3 – 4+ years of relevant experience
- Organized, responsible, dependable with the ability to work in a team environment
Additional Qualifications (nice to have)
- Experience in the use of Master Controls and LIMS for manufacturing applications
- Experience with product transfers or new product implementations
- ERP implementation experience and operational experience – Net Suite preferred but not required
- Working knowledge of 5S and Lean Manufacturing Principles
Argonaut Manufacturing Services, Inc. is proud to be an equal opportunity employer committed to providing employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age or disability, or any other class protected by Federal, State or local laws. Argonaut complies with all employment eligibility verification requirements of the Immigration and Nationality Act and all must have the authorization to work in the US.