Scientist I or II, R & D Lyophilization

Reporting to the R&D Manager, the incumbent in this role will be accountable for assisting in the development and support of all activities associated with the feasibility, development and transfer of lyophilized products developed in R&D to a Manufacturing/Production setting. This role will be a liaison between the R&D Manager, Junior Scientists, Clients and Manufacturing.

The ideal candidate for the Scientist I position will have 6-8+ years of experience and for the Scientist II position, 8-10+ years’ experience at the bench with a background in Chemistry, Biochemistry, Molecular Biology, Biology or other related science field. The ideal candidate will also have a strong background in product development and manufacturing, as well as some experience managing small teams.

This role requires someone with the ability to take initiative and work autonomously under minimal supervision within a multi-faceted team. Strong communication skills are a must as this is a customer facing R&D role. The preferred candidate will have a keen attention to detail and a passion for efficiency, innovation and problem solving with a focus on quality. This role requires a flexible work schedule.

Specific Responsibilities

  • Assist in the development of client products for lyophilization – this includes designing, executing on experimental protocols and recording results, observations, and ideas for improvement throughout the process
  • Work as part of a team to meet each project goal in a timely manner and communicating any delays to the appropriate person
  • Scale-Up R&D formulations and transfer them to Manufacturing/Production – being able to critically review a protocol and determine feasibility in Manufacturing/Production and make recommendations
  • Assist in developing processes that are well-documented, robust, and can be easily transferred to production to create quality products repeatably
  • Work actively with Manufacturing to solve challenges in the production environment related to specification discrepancies, material dispositions and process changes
  • Work with Quality Control to assure proper product specifications are in place and assist in product qualifications and validations
  • Communicate with clients and project managers on a regular basis – scheduling and communicating reagent deliveries to/from client/project managers as well as communicating project timelines and delivery dates to the customer
  • Be available 24/7 for attending to processes and equipment

Additional responsibilities will include, but are not limited to the following:

  • Be a liaison between Client, R&D and Manufacturing – work closely within a team to transfer protocols developed in R&D to Manufacturing and make sure that processes are robust
  • Work with our internal QC team to communicate client’s needs for testing and make sure that internal/external specifications and metrics are met
  • Meet weekly with manager to determine project timelines and responsibilities for each client
  • Work closely with project managers to maintain client expectations
  • Execute on experimental protocols and writing up reports/summaries of results
  • Assist in developing, writing, and editing SOP documents during tech transfer
  • Train manufacturing personnel on new protocols, assist with ordering of raw materials as well as hardware required for each process being transferred
  • Critically think about scale up processes based on R&D runs – proactively determine where issues could arise with scale-up of products, determine feasibility of scale up process and provide recommendations
  • Process Improvement – assist in creating robust and repeatable processes for each client, look for process inefficiencies and provide solutions
  • Strive to develop products and processes that meet or exceed our quality system requirements
  • Mentor junior level scientists
  • Create strong relationships with our clients, able to independently manage a client and their project from R&D through Product Transfer
  • Work closely with the Sales Team to develop a detailed path to take a client’s product from Feasibility through Product Transfer
  • Proven track record for process improvement, must be able to critically think about how to write, develop and improve protocols that build quality and robust products
  • Subject matter expert on scale up process and manufacturing processes
  • Maintain lab notebooks that are accurate and detailed

Position Requirements and Experience

  • Bachelor’s or Master’s Degree in a relevant field (Biology, Molecular Biology, Biochemistry, BioEngineering or similar) with a minimum of 6 years of lab experience in an academic or biotech setting
  • Subject matter expert in the basic principles of molecular biology, biochemistry and immunochemistry and is able to apply those principles to experimental designs and plans
  • Project Management skills highly desirable
  • Experience with lyophilization is highly desirable but not required
  • Strong background in reagent formulation, DNA amplification, and material inspection methods
  • Strong background in laboratory skills such as proper pipette mechanisms, liquid measurements, basic molecular biology equations – experience in cGMP settings, is a plus
  • Ability to multi-task, handle multiple projects at one time and adaptability to change priorities based on business needs and competitive intelligence
  • Must be organized, and able to work with Microsoft Project a plus
  • Ability to manage time effectively and schedule projects
  • Excellent written and oral communication skills
  • Effective interpersonal, teaming and relationship management skills
  • Good analytical and problem-solving skills
  • Excellent attention to detail

Expected Behaviors include:

  • Being proactive and taking initiative
  • Proven leadership abilities
  • Able to mentor and lead a small team
  • Courageously speak up, provide feedback, challenge assumptions, and communicate openly and honestly
  • Demonstrate high energy and enthusiasm
  • Collaboration and Teamwork
  • Pragmatism
  • Accountability
  • Adaptability
  • Agility
  • Demonstrated skills in establishing and maintain collegial relationships
  • Remain empathetic and supportive under pressure
  • Able to resolve emerging issues expeditiously
  • Scientific Knowledge

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 the quality and regulatory expertise to assure the highest in quality manufacturing and supply chain excellence.

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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