Manufacturing Coordinator - San Diego, CA | Biospace
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Manufacturing Coordinator

BioDuro,LLC

Location:
San Diego, CA
Posted Date:
8/7/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
High school or equivalent
Areas of Expertise Desired:
Manufacturing, Project Management,

Job Description

We are in relentless pursuit of your success.  Joining the team at BioDuro means you’ve signed up for a world of opportunity, collaboration and possibility. Come grow and develop your career here by working closely with a team of seasoned experts and rising stars.  Contribute your talents to meaningful projects that impact the lives of patients around the world.   At BioDuro, leadership is exhibited at every level. No matter what your role, all of our employees are empowered to lead us in our relentless pursuit of success.

WHO WE ARE
Our core principles of flexibility, visibility and reliability make us a trusted name and a catalyst in bringing the best pharmaceutical solutions to our global community partners.  Embedded in everything we do at BioDuro is the reality that the products we help create, have the potential to cure patients.

WHAT WE DO
BioDuro is a leading contract development and manufacturing organization.  We were founded on the principle of scientific innovation and we are fiercely committed to Collaboration and Possibility.  Our cutting-edge drug delivery and bioavailability enhancement technologies allow us to provide solutions for challenging clinical trial projects from Phase 0 to Phase III studies. We provide integrated quality services to help our clients bring their products from development to commercialization in our 44,000-sq. ft. facility.

WHAT YOU’LL DO
We have an immediate opening for  a Manufacturing Coordinator.

Essential Job Functions
•   Collaborate with Manufacturing, Materials, Project Management, QC and QA to plan, prepare and monitor manufacturing batches
•   Write and revise Manufacturing Batch Records, Specifications, SOPs and other technical documents
•   Primary contract for client interaction regarding GMP production related activities
•   Source and procure ancillary items and small equipment for GMP production use
•   Conduct departmental training exercises; Collaborate with QA team to assure that training records are current and appropriate for participation in execution of Batch Records
•   Assist in reviewing and completing all documentation in compliance with GMP
•   Production Project Management including use of project management software (e.g. Basecamp), and assisting finance and project management team in capturing billable events
•   Assist in scheduling usage of GMP areas and equipment
•   Source and procure raw materials for GMP production use
•   Coordinate external vendors in support of GMP manufacturing operations
•   Coordinate with internal resources for maintenance related activities
•   Strictly follows company policy on controlled substances
•   Other duties as assigned by senior management

Requirements

Experience Required
High School Diploma/GED with 5 years of experience in a GMP environment
BS in Chemistry or related field with 2 years of experience in a GMP environment


Experience writing batch records is required.
Proven leadership experience with ability to train/mentor staff
Experience with manufacturing solid dosage forms
Ability to troubleshoot analytical issues and conduct manufacturing investigations.

Benefits
BioDuro provides opportunities to work in beautiful Torrey Pines, CA or across the globe.  We are proud to offer competitive salaries and benefits to our employees.  In addition to full health benefits, paid time off, bonus and a retirement savings plan, BioDuro provides employees with daily free catered lunch, a company garden, and a variety of engaging employee events.  We reward and promote employees who exhibit the values of Accountability, Respect, Tenacity, Results and Integrity.


EOE and Accommodation
We value diversity and are proud to be an equal opportunity employer.  BioDuro provides reasonable accommodation in job application procedures for qualified individuals with disabilities and disabled veterans. You may also request an accommodation with our team directly.