Associate Scientist, Lyo

Corporate Overview

Argonaut Manufacturing Services, Inc. is a contract manufacturer of life science reagent consumables and Biopharmaceutical drug products. The company offers cGMP manufacturing compliant 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 for these clients.

Position and Scope

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

The ideal candidate will have 2-5 years’ experience at the bench with a background in Chemistry, Biochemistry, Molecular Biology, Biology or other related science field.

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.

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 repeatedly
  • 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

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
  • Execute on experimental protocols and write 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
  • Create strong relationships with lab personnel on the manufacturing team
  • Become a subject matter expert on scale up process and manufacturing processes
  • Assist in picking up client reagents and shipping materials to clients, as needed
  • Maintain lab notebooks that are accurate and detailed
  • Manage lab supplies – actively keep a count of inventory, proactively order lab materials as needed, follow up on orders, pick up orders
  • Maintain an organized and clean lab – cleaning floors, taking out trash, cleaning lab items to reduce potential for contamination

Position Requirements and Experience

  • Bachelor’s degree in a relevant field (Biology, Molecular Biology, Computational Biology, BioChemistry or BioEngineering) with at least 1-2 years of relevant work experience in a similar industry
  • Understands the basic principles of molecular biology, biochemistry and immunochemistry and is able to apply those principles to experimental designs and plans
  • Experience with lyophilization is highly desirable but not required
  • Experience in reagent formulation, DNA amplification, and material inspection methods
  • Basic laboratory skills such as proper pipette mechanisms, liquid measurements, basic molecular biology equations – experience in cGMP settings, is a plus
  • Ability to multitask, handle multiple projects at one time and adaptability to change priorities based on business needs and competitive intelligence
  • 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
  • Courageously speaking up, providing feedback, challenging assumptions and communicating openly and honestly
  • Demonstrated high energy and enthusiasm
  • Collaboration and Teamwork
  • Pragmatism
  • Accountability
  • Adaptability
  • Agility
  • Availability and accessibility 24/7
  • Demonstrated skills in establishing and maintain collegial relationships
  • Remaining empathetic and supportive under pressure
  • Ability to resolve emerging issues expeditiously
  • Scientific Knowledge

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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