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The Senior Research Associate 1 (Contractor), Product Development plans, drives and manages data verification of laboratory notebooks, protocols, reports, and regulatory filings. He/she ensures the accuracy of records and compliance to Halozyme’s Standard Operating Procedures, regulatory requirements, and current industry standards/practices. Additional support may include supporting aspects of technical writing for reports or regulatory dossier sections, bioprocess development, and analytical lifecycle
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These may include, but are not limited to:
Perform timely data verification and technical review of laboratory notebooks, protocols, reports, and regulatory filings for accuracy
Manage the data verification process and all personnel involved with the data verification program for the Product Development department
Act as a liaison between Product Development and other departments to ensure documents are reviewed and approved according to set deadlines
Recommend and enforce guidelines for good documentation practices in laboratory notebooks, protocols, reports, and regulatory filings among SMEs and document authors
Recommend and enforce innovative process ideas to increase efficiency and accuracy of data verification and document review
Support technical writing of reports or regulatory dossier sections
Generate and/or revise analytical test method procedures and standard operation procedures as needed
Support analytical lifecycle activities which includes but is not limited to CDMO investigational support, method development studies, method monitoring, method qualifications/validations, and method transfers. Support bioprocess development activities which includes but is not limited to buffer preparations, sample organization, and sample submissions for analytical testing
Communicate status/results/problems clearly to supervisor and stakeholders
ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:
Meets with supervisor for guidance on technical or scientific issues and on prioritization.
Comply with established company policies and procedures, objectives, quality assurance program, safety and environmental standards.
Recommend and implement innovative process ideas to increase efficiency of laboratory management activities
May present to internal groups
Attends relevant meetings and seminars
Other duties as assigned
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
Bachelor’s Degree in relevant scientific discipline or equivalent with a minimum of 5 years of experience (an equivalent combination of experience and education may be considered)
Familiarity with a variety of analytical methods (e.g. compendial methods, isoelectric focusing, capillary electrophoresis, chromatography, ELISA, and potency methods) and the ability to work independently with a high degree of accuracy is desired
Familiarity and experience withregulatory filings (NDA, IND, BLA, international filings), is preferred
Strong organization skills with great attention to details
Great oral and written communication, and interpersonal skills
Demonstrated willingness and ability to learn and apply new techniques
Prior pharmaceutical and biotech industry experience preferred
General knowledge in typical analytical assays for biopharmaceuticals preferred
Working knowledge of GLP, GMP, and regulatory guidelines in biopharmaceuticals preferred
TECHNICAL KNOWLEDGE REQUIRED:
Equipment:PC, scanners, facsimile machine, voice mail and e-mail systems, and common office machines, or ability to be trained. Knowledge of other equipment required: N/A
Software Knowledge: Windows, MS Office (Outlook, Word, Excel, PowerPoint). Knowledge of other software required: N/A
INTERNAL AND EXTERNAL RELATIONSHIPS:
Ability to perform as part of a team working with the Product development group
Interact with SMEs of the Product Development team, the Facility team, and with outside vendors
EFFORT REQUIRED/ENVIRONMENTAL CONDITIONS:
Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 20 lbs. may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.
Laboratory Activities, if applicable:Biology and chemical laboratory environments experience needed. Environmental health and safety requirements also apply.
Travel may be required up to 5% of your time.
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