Location: Redwood City, CA or Remote
Rezolute is seeking a highly motivated contractor to join our MSAT team as Principal Scientist/Associate Director. The individual will play a critical role in supporting the RZ358 drug substance (DS) process validation activities and Process Performance Qualification (PPQ) manufacturing campaign. The individual will partner with cross-functional teams to ensure the successful DS process validation for RZ358 and enable global market authorization applications.
Rezolute’s culture enables remote work through the use of virtual communication tools. This role will be enabled to be a part of daily CMC activity at both Redwood City, CA and Bend, OR offices and will be expected to interact face to face with the CDMO network as required.
- Closely collaborate with internal teams and external CDMOs to perform MSAT activities with a focus on risk assessments, process verification/validation protocols and reports, PPQ batch manufacturing, and continuous process verification.
- Provide PIP (Person-In-Plant) manufacturing oversight.
- Perform technical review of cGMP manufacturing related documentation.
- Provide technical leadership for the investigation of deviations and change control management.
- Author technical reports to support regulatory filings.
- Bachelor’s degree (or higher) in a related field with at least 7 years experience in biologics drug substance process development and cGMP manufacturing; direct mAb manufacturing experience is preferred; PPQ experience is plus.
- Strong technical expertise in Biologics downstream processes (Affinity, AEX, CEX, VF, and UF/DF unit operation) and working knowledge/experience in CHO cell culture processes.
- A strong sense of urgency with regards to work duty and timeline
- Ability to work in a highly collaborative and virtual environment leveraging external collaborations to accomplish individual and team goals.
- Must be willing to travel domestically as required (up to 25%).
- Detail-oriented with excellent verbal and written communication skills
- Act with HONOR: Honesty, Open with Direct Communication, Nimbleness, Open-minded, Respect.
Interested and qualified candidates should send their resume to firstname.lastname@example.org to the attention of Human Resources.
This is a contract role with an expected duration of 6 – 9 months. Rezolute (RZLT) currently anticipates the hourly compensation for the Contract Associate Director, Manufacturing Sciences & Technology role to range from $84.13 to $96.15 and will depend, in part, on the successful candidate’s geographical location and their qualifications for the role, including education and experience. The compensation described above is subject to change and could be higher or lower than the range described based on current market survey data and the qualifications, education, experience and geographical location of the selected candidate.
We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.