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9 days old

Sr. Analytical Development Scientist

Kelly Services
Berkeley, CA 94701
For over 25 years Kelly Science & Clinical has been connecting scientific professionals with industry leading job opportunities. Today we are excited to be hiring a **_Sr. Analytical Development Scientist_** for a therapeutics company in Berkeley, CA. The **_Sr. Scientist_** will utilize their bioassay expertise to become a subject matter expert in immunoassays and will be a key member of the analytical development team leading the development and qualification of analytical methods for monoclonal and bispecific antibodies.

**Responsibilities:**


+ Timely development of analytical methods supporting their qualification/validation and transfer to quality control and to external contract organizations where they will be used in CGMP product testing.

+ Design and execute scientific studies and will collaborate extensively with cross functional groups with representatives from contract manufacturing and testing organizations

+ Meet objectives for the development and qualification/validation of assays implementing technologies such as ELISA and cell based assays (e.g. gene expression bioassay) to test and characterize proteins and related compounds

+ Lead support of pharmaceutical products throughout their lifecycle, such as development samples from Upstream Process Development and Downstream Purification Development, Formulation Development, DS and DP Manufacturing

+ Write technical development reports and give oral presentations of data at departmental or interdepartmental meetings.

+ Write, review and edit SOPs and Test Methods for new procedures and assays; review, edit and revise existing SOPs to reflect changes in procedures.

+ Act as analytical subject matter expert and contribute to the authoring and review of regulatory CMC sections (IND, BLA).

+ Maintain lab compliance by performing routine housekeeping, including support of analytical instrument maintenance, ordering and stocking of lab supplies, maintaining of reagents, sample management, and compliance to safety regulations.


**Requirements:**


+ PhD with 6 years of experience, Masters with 8 years of experience, or Bachelors degree in a Scientific field with at least 10+ years of relevant experience in a development or GMP environment, especially with protein therapeutics

+ Immunoassay and cell based assay (bioassay) development and validation

+ Excellent observation and attention to detail and accuracy for record keeping and documentation

+ Knowledge of cGMPs.

+ Ability to work independently, and as part of a team on assigned projects

+ Prior leadership or project management experience is highly desirable.

+ Experience in the design, development, and validation of analytical methods and product characterization for monoclonal antibody therapeutics is strongly preferred.


+ Ability to adapt to changes, assess priorities and remain focused on goals


**_Apply today to start a conversation on Whats Next for your Career!_**


+ Please feel free to schedule an interview directly with Athena to learn more: https://calendly.com/athp320/interview

+ Additional questions may also be e-mailed to athena.parker@kellyscientific.com.


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-09-21 Expires: 2022-10-22

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Sr. Analytical Development Scientist

Kelly Services
Berkeley, CA 94701

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