199641 - Scientist I
Industry
SCI
Region
CA-Southern California - San Diego
City
Carlsbad
State
CA
Rate
$28 to $30.00 DOE
Duration
12 months
Description
Chipton-Ross is seeking a Scientist I for a contract opportunity in Carlsbad, CA.

OBJECTIVE:
We are looking for a talented QC Scientist I to join our QC-Analytical Services group to support in-process testing, release, and stability testing of plasmid drug substance and drug product for clinical and commercial supplies as per the applicable industry and company standards.

RESPONSIBILITIES:
Order lab supplies maintain required level of inventory for continuous work. Perform physicochemical testing of in-process, release, and stability testing. Assist scientist involved in testing plasmid content, plasmid isoform quantitation, residual DNA, residual RNA, residual host cell proteins and final plasmid drug substance and drug product release testing. Assist in work related to QC plasmid assay to support characterization, in-process, release, and stability of incoming cell banks and final products for the release and monitoring of plasmids, cell, and gene therapy products. Assis in the investigation of non-conformance materials, corrective, and preventive actions. Assist in the, revision, review of regulatory analytical procedures, validation/transfer protocols, work instructions, guidance, SOPs and generate reports as per the applicable regulatory and industry standards. Work closely with R&D, manufacturing, quality, and project management teams to execute assays that meet customer and manufacturing needs in support of department, site, and corporate objectives. Assist the team in lab maintenance and document management. Apply principles and practice of quality management systems to ensure work performed meets the applicable compliance and customer requirements. Keep current on Environment, Health & Safety policies, ensure safe environmental and working conditions in the Analytical Sciences labs. Other duties as assigned; travel as needed. Changes to individual responsibilities may occur due to business needs. Other duties that may be determined by the management.

REQUIREMENT:
Knowledge of AcccuSeq, Empower Software, LIMS, SM, eDMS, TrackWise preferred. within a regulated biological and/or pharmaceutical industry, is preferred. Knowledge of plasmid technology, cell biology, virology and or immunology is highly desirable. Knowledge of USA 21 CFR, EudraLex, ICH, USP-NF, Ph. Eur, PDA, and ISPE, preferred.

EDUCATION:
Accredited Bachelor’s degree in Analytical Chemistry, Molecular Biology/Life Science (or closely related discipline).
Preferred BS candidates with 1-2 + years’ experience, Master’s degree with 1 + years’ of direct experience in a regulated biological and/or pharmaceutical industry

WORK HOURS:
Full-Time
Days

Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.

Contact
Zachary Fasano
zfasano@chiptonross.com
CHIPTON-ROSS, INC.
420 Culver Boulevard
Playa Del Rey, CA 90293

Phone: (310) 414-7800 x252 or (800) 927-9318 x252

Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.

Employment will be contingent on candidate clearing pre-employment drug screen and background check.

Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.