Offer summary

Qualifications:

Degree in Life Science or Engineering, preferably in Biochemistry, Analytical Chemistry, or related fields., Advanced degree holders are preferred., Experience in the biotech industry and project management is a plus., Strong understanding of raw materials used in biologics and small molecules..

Key responsibilities:

Manage the development and implementation of raw material specifications.

Interface with cross-functional teams and external suppliers.

Draft specifications based on raw material attributes and control measures.

Facilitate specification development meetings and document changes in compliance with CCMS.

Dale Workforce Solutions (DWS) is a WBENC certified woman owned staffing and talent solution leader, providing information technology and professional staffing to a nationwide client base. We strive to EMPOWER change, ENRICH partnerships and ELEVATE outcomes. Mission: To help our clients advance their business culture with exceptional talent through an intentional focus on agility, diversity, and inclusion. We strive to Empower change, enrich partnerships, elevate outcomes Core Values Integrity, Teamwork, Care, and Agility Simplify: Communicate with clarity, focus and purpose Relationships: Act with integrity, value connections, and build trusted partnerships Impact: Make a difference, be passionate, fun and ﬂexible

Job description

Client: Biotech
Location: Fully remote
Duration: one year + extensions up to 3 years
Rate: up to $44/hr w2

Job Details: Manage the development and implementation of clinical and commercial raw material specifications and other specification related documents. Have an understanding and knowledge of raw materials used in the manufacturing of biologics and small molecules (Media, Chemicals, Excipients, Single-Use Components, Filters, Resins, Primary Containers). Interface cross-functionally within Client (with Process Development, Quality, Supply Chain and other GMP functions) and externally with Client raw material suppliers. Draft specifications based on raw material attributes, where they are used in the Client process and how they should be controlled. Facilitate specification development meetings and generate meeting minutes/action items to partners to ensure completion of tasks. Other responsibilities include acting as a change owner and initiator as part of the Change Control Management System (CCMS) to document changes to global documents in a compliant manner. Skills: Degree in Life Science or Engineering (Biochemistry, Analytical Chemistry, Bio-Manufacturing, Process development, Chemistry, Biology, Engineering); preference will be given to advance degree holders and/or those who have industry and project management experience.

Required profile