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Sr. Scientist Ii, Monoclonal Antibodies

8+ years
$75 - $90 per hour
10 Jan. 23, 2025
Job Description
Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Sr. Scientist II, Monoclonal Antibodies
Location: San Francisco, California
Contract Type: Contract
Compensation: $75 - $90 per hour (based on experience)


Job Overview:

The Sr. Scientist II, Monoclonal Antibodies will lead process development activities for monoclonal antibodies (mAb) intended for clinical studies. This role involves solving complex problems through in-depth analysis and supports the company's efforts to create high-value therapeutics aimed at addressing unmet medical needs. The candidate will manage and execute projects related to the development of monoclonal antibodies, working closely with internal and external teams to ensure successful product development.


Key Responsibilities:

  • Process Development:
    Lead the design, development, and support of upstream and downstream processes for the manufacture of monoclonal antibodies.

  • Project Management:
    Manage multiple activities simultaneously, ensuring that project timelines and milestones are met. Oversee the execution of process/product development tasks and ensure they align with project goals.

  • Technical Leadership:
    Review and approve technical protocols, reports, and GMP batch documentation related to monoclonal antibody production. Ensure processes adhere to regulatory requirements.

  • Regulatory Support:
    Author and review regulatory sections for IND submissions. Provide scientific and technical input to support regulatory filings.

  • Problem Solving & Experimental Design:
    Define complex scientific problems and develop experimental plans based on sound scientific judgment. Recommend new methods, techniques, and evaluation criteria as necessary.

  • Cross-Functional Collaboration:
    Work closely with various internal teams and external organizations to facilitate process development and address scientific challenges.

  • Scientific Innovation:
    Maintain up-to-date knowledge of state-of-the-art scientific principles and techniques related to monoclonal antibody production and contribute to the scientific community by sharing knowledge.

  • Representation:
    May represent the company at external meetings and collaborate with outside organizations to advance research and development efforts.


Required Skills & Qualifications:

  • Education:

    • PhD in a scientific or engineering discipline (or equivalent experience).
    • A minimum of 8 years of work experience in a research or development environment focused on monoclonal antibody production.
    • Exceptional candidates with significant experience in upstream, downstream, and formulation development across monoclonal antibodies may also be considered, even without a PhD.
  • Experience:

    • Proven track record of success in monoclonal antibody production, with expertise in process and product development.
    • Experience working in an FDA-regulated environment and knowledge of GMP requirements is highly desired.
  • Skills:

    • Strong problem-solving capabilities and ability to develop effective experimental plans.
    • Ability to lead projects, manage teams, and meet deadlines.
    • Strong technical proficiency and scientific creativity in monoclonal antibody production.
    • Expertise in FDA regulatory requirements and GMP.
    • Excellent written and oral communication skills with the ability to present technical information to both technical and non-technical audiences.
  • Additional Skills:

    • Familiarity with process development, product development, and documentation within the monoclonal antibody field.
    • Strong project management skills, including the ability to handle multiple projects simultaneously.

Compensation:

  • Hourly Rate: $75 - $90 per hour (based on experience).

How to Apply:

Interested candidates should submit an updated resume that highlights relevant work experience and qualifications.

Clinovo is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.