Associate Scientist I - QC Operations, Biologics Production

Profile

Specific Responsibilities
**MEMBERS ONLY**SIGN UP NOW***. Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining **MEMBERS ONLY**SIGN UP NOW***., you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases. **MEMBERS ONLY**SIGN UP NOW***. Sciences is currently seeking a Senior Research Associate II, QC. The appropriate candidate for the role:
• Leads QC projects and cross-functional projects specific to preparing the Biologics site for Commercial Production
• Bears extensive knowledge in Phase-appropriate regulations for Biologics in-process and release tests.
• Leads training of staff and develops training curriculum when necessary.
• Troubleshoots instruments and test methods.
• Plans and executes assigned experiments that support routine development activities and project goals.
• Experience with Labware LIMS, Empower, SoftMax Pro, WIN KQCL and Trackwise is preferred.
• Experience transferring methods to Contract Labs.
• Writes, revises, and reviews procedures and methods for QC.
• Provides QC expertise and counsel to and on behalf of the organization.
• Investigates QC laboratory investigations, deviations and identifies Corrective and Preventative Actions.
• Reviews GMP In-process and Release data, buffers, and logbooks.
• Drives improvements to existing Quality Systems and develops new Quality Systems that enhance the Biologics business.
• Reviews regulations and makes necessary changes to procedures and methods to ensure the Biologics business complies.
Essential Duties and Job Functions
Lead method validation efforts
Write validation protocols and reports
Perform investigations as required to support commercial products
Revise, improve or develop new methods to support commercial products
Knowledge, Experience and Skills
10 years of experience with AA degree
8 years of experience with BS degree in a relevant scientific discipline.
6 years of experience with MS degree in a relevant scientific discipline.
Experience with Microsoft Office and LIMS.
Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems, and have strong organizational and planning skills.
As an equal opportunity employer, **MEMBERS ONLY**SIGN UP NOW***. Sciences Inc. is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact **** for assistance. For more information about equal employment opportunity protections, please view the EEO is the Law poster. #LI-MM1
As an equal opportunity employer, **MEMBERS ONLY**SIGN UP NOW***. Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without regard to race, color, religion, national origin, gender, age, sexual orientation, disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ****
for assistance.
For more information about equal employment opportunity protections, please view the ‘EEO is the Law’
poster.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
**MEMBERS ONLY**SIGN UP NOW***. provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

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