PRODUCT DEVELOPMENT ASSOCIATE / SR. PRODUCT DEVELOPMENT ASSOCIATE (closed)
PRODUCT DEVELOPMENT ASSOCIATE / SR. PRODUCT DEVELOPMENT ASSOCIATE
Simply Biotech specializes in recruiting exclusively for the biotech community. We are currently seeking multiple Product Development Associates / Senior Product Development Associates for a leading and growing Orange County firm.
The Sr. / Product Development Associate is responsible for planning, conducting and analyzing experiments leading to validation of diagnostic tests in the field of methylation-related oncology. The selected candidate works in a team and needs to communicate relevant information to professional colleagues and to participate constructively in decision making that will impact the performances of the final product. The incumbent is responsible for compliance to all applicable regulations including but not limited to the Food and Drug Administration, ISO and state and federal requirements. The Product Development Associates / Senior Product Development Associates will:
* Be responsible for the development and optimization of molecular assays in collaboration with others on assigned projects. Meets deadlines specified in overall project schedules.
* Elaborate detailed protocols to validate research hypothesis and confirm product compliance with predefine expected performances. Plans and executes simple experiments independently. May plan complex experiments independently.
* Perform lab work according to internal quality standards, document accurately the results and archive them accordingly in order to facilitate downstream work (intellectual property, regulatory affairs or research follow-ups). Maintains strict laboratory notebooks and research records.
* Analyze results using statistical methods, control for consistency with previous work, summarize and communicate main outcomes to team members.
* Participate in the evaluation and creation of new methods and procedures under the direction of the Director of Product Development.
* Prepare technical reports, summaries, protocols and quantitative analyses that accurately and clearly communicate necessary information.
* Participate in creation of all necessary documentation to support product manufacture, including manufacturing specifications, QC test procedures, raw material specifications and validation protocols.
* Apply professional concepts, in accordance with Company objectives to solve moderate to moderately complex problems in creative and effective ways.
* Maintain high level of professional expertise through familiarity with scientific literature. May participate in scientific conferences and contributes to scientific journals.
* Provide necessary training to Product Development team members and other personnel as required.
* May be responsible for identifying patentable inventions.
* Adapt to changes in processes, accepting approved changes and learning new tasks.
* Participate in continuing education programs, (mandatory and non-mandatory).
* Good knowledge and technical insight of molecular biology, particularly PCR and MSP, DNA extraction and modification.
* Continuously provide detailed and accurate work, high personal quality standards.
* Knowledge of quality systems and quality system regulations. Knowledge of ISO standards (ISO13485, ISO 9001-2008) a plus.
The Product Development Associates / Senior Product Development Associates will possess the following qualifications:
* Bachelors degree in life science or equivalent scientific discipline and 5-8 years related work experience OR Masters degree in life science or equivalent scientific discipline and 3-5 years related work experience OR Ph.D. degree in life science or equivalent scientific discipline and 1-3 years related work experience.
* Requisite industry experience
* Ability to read, analyze, and interpret such documents as pertaining to the performance and analysis of analytical testing. This could include but not limited to reagent package inserts, and standard operating procedures.
* Ability to effectively present information and respond to questions from management, clients, auditors and internal customers.
* Knowledge of basic computer skills such as Microsoft Office Suite to include Excel and Word.
* Previous experience with Laboratory Information Systems, preferred.