Staff Scientist Senior Manager Reagent Manufacturing
Staff Scientist Senior Manager Reagent Manufacturing
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Salary Not Disclosed
1 Vacancy
Job Description
About Glyphic:
At Glyphic Biotechnologies we plan to create the protein revolution for which scientists and researchers have been waiting. We are developing a massively parallel singlemolecule proteome sequencing platform that will transform life science discovery and usher in a new era of insights into human biology and disease. To date we have raised >$50M from venture partners and nondilutive grant funding to achieve our vision of next generation proteome sequencing.
What we are looking for in you:
Glyphic is seeking an experienced reagent manufacturing leader who will report to the Chief Operating Officer and anchor a newly formed Reagent Manufacturing team focused on standardizing and scalingup Glyphics production and R&D reagents in support of a commercial launch. This will be a unique opportunity to define and run new manufacturing processes build out a dedicated lab and scaleup by 10100X in a highly controlled environment.
The ideal candidate should have extensive experience in developing and executing production strategies to ensure longterm reagent supply and a proven ability to translate research protocols into a controlled production environment.
The employee will need to be handson in designing and running platebased manufacturing campaigns using automated liquid handling platforms in addition to literscale bulk reagent preparation. A successful candidate will need to work effectively with internal stakeholders (R&D Product Development Finance Operations Quality) and external vendors to meet current supply obligations and enable future roadmaps. Experience in establishing new reagent manufacturing processes from protocol design to instrumentation selection/qualification in a controlled environment is highly desirable.
Responsibilities:
Perform complex reagent production protocols and comprehensive QC testing
Track weekly reagent utilization and generate capacity/demand forecasts to ensure stable and reliable supply
Manage endtoend inventory system for raw materials and finished reagents
Order placement and delivery tracking
Minimum stock levels and order quantities
Raw material lead times
Expiration management
Perform stability studies to determine shelf life and optimal environmental storage conditions
Work with external vendors to implement longterm sourcing/supply agreements evaluate alternative suppliers for critical reagents and perform vendor qualifications
Drive process optimization initiatives to reduce costs increase production efficiency and improve consistency
Partner with R&D to define reagent specifications and requirements while ensuring that manufacturability scalability and cost are considered as part of all new reagent programs.
Troubleshoot production issues perform root cause analysis and drive corrective actions
Develop and maintain SOPs and BOMs for all Glyphic reagents
Maintain detailed batch records and ensure quality/regulatory compliance
Partner with QC to define validate and monitor material quality
Required Competencies:
BS/MS in Biology Chemistry or a related field with a strong foundation in analytical chemistry (PhD preferred)
6 years of reagent manufacturing experience with an emphasis on reagents required for protein and/or DNA synthesis & sequencing
Extensive experience in solution preparation techniques and analytical methodologies
Experience running reagent quality control testing stability studies and comparability programs
Experience establishing and managing internal reagent manufacturing operations external supply partnerships and supply chains in support of new product launches
Experience with Lean Manufacturing principles and process optimization
Proven ability to support ontime customer order fulfillment while ensuring product quality requirements
Strong background in process design quality statistics and structured problemsolving methodologies
Experience with Lean Manufacturing principles and process optimization
Strong documentation skills including SOPs batch records and inventory management systems
Preferred experience with DNA synthesis/purification
Preferred experience with GLP/cGMP and ISO quality standards
Preferred experience with automated liquid handling instrumentation
Benefits and Perks:
Employee Stock Option Plan
100 Health Plan Coverage for Employees & Dependents (Medical Dental & Vision)
Employer Retirement Contributions to 401(k)
Generous Paid Time Off
Paid Maternity and Paternity Leave
Health & Wellbeing Program
Office Snacks and Beverages
Regular Team Bonding Activities
We are an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Individuals seeking employment at Glyphic Biotechnologies are considered without regard to race color religion national origin age sex marital status ancestry physical or mental disability veteran status gender identity or sexual orientation.
Required Experience:
Senior Manager
Employment Type
Full-Time
