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Scientist, Quality Control

  • Anywhere

Company :
CSBio

Location :
Menlo Park, California

Expiry Date :
Tue, 17 Nov 2020 23:59:59 GMT

Apply Job :
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Description :
CSBio is a fast-paced growing peptide CMO founded in 1993. Our initial products were a complete line of automated synthesizers for manufacturing and process development, with a focus on cGMP production. In 1994, we opened our custom peptide facility and began producing high quality compounds for research organizations and pharmaceutical companies worldwide. In 2004, we opened our peptide production facility in Menlo Park, CA and in 2014, we expanded our production capability through the addition of a new, state of the art building dedicated to cGMP peptide production. In 2017, we passed a FDA inspection and were recommended to be approved for commercial drug substance manufacturing. In 2019, we expanded into Milpitas, CA for non-clinical production and are currently under construction for a new dedicated cGMP clinical peptide production facility.

Job Duties:

* Lead, provide, participate and execute analytical instrument qualification and equipment validation activities including development and execution of IQ/OQ/PQ Protocols/Reports
* Execute equipment troubleshooting and preventative maintenance activities to support QC lab operation in particular chromatography systems such as HPLC/UPLC, GC, in addition to MS, TOC, FTIR, UV-VIS, Karl Fisher titrators and others
* Write and assist others in writing protocols, methods, and reports to site requirements
* Actively support and train other chemists and technicians within area of expertise
* Lead in the maintenance of a high-quality and safe laboratory workplace
* Maintain and help support a working laboratory, including providing leadership in instrument troubleshooting, validation and qualification, maintenance and provision of laboratory supplies.
* Work in a team environment by communicating, leading, and assisting other team members

Competencies:

* To perform the job successfully, an individual should demonstrate the following competencies:
* Problem Solving – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations.
* Teamwork – Balances team and individual responsibilities; Exhibits objectivity and openness to others’ views; Gives and welcomes feedback; Supports everyone’s efforts to succeed.
* Organizational Support – Follows policies and procedures; Completes tasks correctly and on time; Supports organization’s goals and values.
* Motivation – Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence.
* Adaptability – Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.

Requirements

Education Requirements:

* Bachelors degree in Chemistry, Biochemistry, or other relevant scientific field with 7-10 years experience in cGMP environment.
* Masters or PhD degree in relevant scientific field preferred

Experience Requirements:

* Strong knowledge and understanding of analytical instruments and instrument qualification
* Troubleshooting and problem solving ability, and excellent oral and written communication skills
* Ability to multitask, and prioritize objectives from various projects, adhere to strict deadlines,
* Analytical laboratory operations and laboratory technical leadership, especially in chromatography

* Strong GMP knowledge and in depth understanding of ICH and FDA regulations.
* Thorough understanding of problem-solving and quality improvement tools and techniques
* Ability to work effectively and collaboratively in a cross-functional team within a fast-paced environment

Benefits

* Medical, dental, and vision insurance (Kaiser HMO or BlueShield PPO. Employer pays 85% for Employee and 50% for Employees family; Dental: Aetna Dental, Delta Dental, Guardian Dental, MetLife Dental. Vision: VSP and Aetna EyeMed)
* Basic life ($20,000 paid by company) and supplemental life insurance (optional supplemental).
* Disability insurance 50% standard employer paid.
* 401k 10% 1:1 match
* PTO policy. 10 days PTO
* Holidays policy: 8 days floating PTO
* Additional companywide paid holiday during Thanksgiving Thursday through Sunday, and between December 24 to January 1
* Carpool, clean air vehicle, and cell phone reimbursement
* Free shuttle program (Union City Bart to HQ, San Francisco to HQ, Palo Alto Caltrain to HQ)
* Employee rewards and recognition program
* Free membership to Ignite Biofitness (Fitness center with salt water lap pool, rock climbing wall, weight lifting machines, treadmill, and ellipticals.
* Company organized social events
* Catered lunch on all federal holidays, Saturdays & Sundays
* Quarterly sponsored team building activities