Technical Operations Manager

Corporate Overview

Argonaut Manufacturing Services Inc. is a contract manufacturing organization (CMO) headquartered in Carlsbad, CA. The company is dedicated to serving highly innovative companies in the biopharmaceutical and molecular diagnostics industries. Argonaut is a full service, cost-effective partner, providing complete solutions in the areas of formulation, filling and final kitting of reagents and consumables. Argonaut provides quality and regulatory expertise to assure the highest in quality manufacturing and supply chain excellence.

Position and Scope

Argonaut Manufacturing Services has an immediate opening for a scientist with extensive knowledge in molecular biology to support our formulation, filling and tech transfer operations. Formulations range in scale and are manufactured in a controlled environment. The role will lead the Tech Transfer team and assist with organization and execution of production flows as well as documentation of production results for our operation’s team. 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 lab space, SOPs and laboratory equipment. Strong time management and organization skills along with interpersonal skills are needed for this exciting new opportunity to help create a highly efficient manufacturing team.

Specific Responsibilities

The successful candidate will have working knowledge in the following skills:

  • Aseptic techniques
  • Scales/balances, pH/Conductivity meters, Mixers and stir plates
  • Spectrophotometer operation (Nanodrop), End-Point and Quantitative (real-time) PCR, and Reverse Transcriptase PCR
  • Cloning and Transformations
  • Small/Medium Scale Nucleic Acid Purification
  • Polyacrylamide and Agarose Gel Electrophoresis
  • Good documentation practices
  • Excellent problem solving / troubleshooting skills and the ability to analyze and interpret data to make business-critical decisions
  • Design and execute validation experiments
  • Quality system compliance while working in a cGMP and ISO13485 production environment
  • Be a mentor and train manufacturing team members, providing technical guidance and leadership, as necessary
  • Work independently and also in a team-based environment effectively
  • Create and revise manufacturing documentation, processing documents, SOPs, manufacturing pilot plans, etc.
  • Create an indented bill of materials, provide production cycle time analysis and project estimates for manufacturing project and engineering runs
  • Serving as a subject matter expert for manufacturing during varied audits by customers and regulatory bodies
  • Advise the manager of factors that may affect 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)

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
  • Strong communication skills and the ability to work with and lead cross functional teams
  • Be organized, responsible, dependable with the ability to work in a team environment
  • Experience developing and following standard operating procedures while following good documentation practices
  • Attention to detail and disciplined in execution
  • Strong initiative and willingness to take ownership and drive projects to completion
  • Interest, ability, and willingness to work in the production lab for extended periods of time

Qualifications

  • BS in Molecular Biology or Biochemistry and 2+ years of experience in industrial environment (manufacturing or R&D) with focus on Molecular Biology or MS in Molecular Biology or Biochemistry 2+ years of relevant experience

Preferred Qualifications

  • Hands-on experience in Molecular Biology (2 years) with proven skills of high-throughput methods for DNA manipulation methods, DNA cloning, DNA preparation, purification and quantification methods, sequencing, microarray, HPLC and protein purification
  • Proven knowledge in process validation
  • 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

Additional Qualifications (nice to have)

  • Experienced 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 Drug Product/Substance manufacturing

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.

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