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Manufacturing Team Lead - Woodinville, United States - Inventprise LLC
Description
Job DescriptionJob Description Salary:
$ $39.00 /Hr
Title :
Manufacturing Team Lead
Overtime Status:
Non-Exempt
Employment Status:
Full-Time
Pay Range:
$ $39.00 /hourly DOE
The hiring pay range for this position is $36.00 to $39.00 per hour based on skills, education, and experience relevant to this role.
We do this by developing novel vaccines targeting infectious diseases for which there are no current preventive interventions or by optimizing currently marketed vaccines to provide a broader spectrum of protection, making them cheaper and more stable than before.
We aspire to provide breakthrough public health interventions for all populations, globally. Inventprise is led by pioneers in vaccine discovery, seasoned experts in manufacturing and vaccine development, and proven commercialization veterans.At Inventprise, we believe our people are our most valuable asset.
We are strongly committed to a range of workplace programs that support the well-being, growth, and engagement of our employees and our business.
What we offer:
Benefits:
Effective the first of the month following the date of hire, employees are eligible to participate in the following Inventprise employee benefit programs:
Medical, Dental, Vision, FSA, or
HSA:
Currently Inventprise contributes 80% toward the Medical, Dental, and Vision coverage for the employee, and enrolled spouse and dependents.
Medical plans are currently provided through Premera Blue Cross.
401(k) program: Inventprise contributes 3% of employee base pay each pay period to their 401(k) account. Employee contributions are at the discretion of the employee.
Paid Time Off:
Employees start PTO accruals at the rate of 5.83 hours each pay period - annualized equivalent of 140 hours/year.
Paid Holidays:
Inventprise offers 9 paid holidays each year: New Year's Day, Memorial Day, Independence Day, Labor Day, Thanksgiving Day, Day after Thanksgiving Day, Christmas Day, and two floating holidays.
Stock & Bonus Plans:
Employees are eligible to participate in the Company's Bonus and Stock Award Plans.
Summary:
Essential Functions:
Managing the day-to-day activities of the upstream, downstream, conjugation and/or formulation team and delegating tasks
Motivating the team to achieve organizational goals and developing and implementing a timeline to achieve targets.
Reviewing batch records and timely submission to QA department
Assist technology receipt of Production, purification of Polysaccharides, proteins, bulk conjugates and vaccine formulation technology from R&D and their transfer to large scale manufacturing using different state of the art techniques.
Assist senior staff in experiments designed to develop new or improve existing upstream, downstream, conjugation and formulation processes and investigate problems related to biological products, as required.
Assist inproduction/purification
processes of polysaccharides, proteins, conjugation and/or formulation in cGMP environment, Comply with all relevant Safety and cGMP procedures.
Write and maintain documentation of work performed as per cGMP requirement
Assist and Train other collogues as needed for cGMP manufacturing.
Perform shake flask culture, cell banking, fermentation, harvest clarification, normal and tangential flow filtration, homogenization, conjugation, chromatography techniques and/or formulation as needed.
Maintain accurate and complete laboratory notebook capturing protocols, results, and observations. Interpret data to form sound conclusions and perform experimental troubleshooting on a routine basisTimely document integrated experimental outcomes in presentations and research and developmental reports
Communicates work orally, in writing and in presentation format by treating reports and data with a high level of integrity and ethics
Hands on work will be required in small and large scale including, but not limited to, upstream, downstream, conjugation, formulation and lyophilization processes as needed
Ability to troubleshoot problems, take corrective actions to solve the problem and generate results on time
Write and or assist in writing MBRs, SOPs and other controlled documents in a detailed and accurate fashion and maintain documentation of work performed as per cGMP requirement.
Contribute to drafting regulatory filing documentationPerform equipment set-up, sterilization, daily operation, sampling etc.
Support a compliant laboratory operation in accordance with SOPs, internal procedures, and policies.
Assist in developing procedures (SOPs), Assist in writing MBRs, SOPs and other controlled documents in a detailed and accurate fashion
Education, Experience & Skills:
Masters degree in relevant field e.g. Biochemistry, Chemistry, Microbiology, Biotechniology, Bio-process technology, Immunology is required. Advanced degree, specifically in biological sciences is preferred.
Minimum of 6 years of experience in the biotechnology or pharmaceutical industries, in a multi-disciplinary, global environment.
Experience in process development, more specifically in chemical conjugation is highly desired with a sound knowledge of organic chemistry and /or biochemistry, techniques like 1-D and 2-D NMRs, Mass spectroscopy, HPLC, HP-SEC-MALLS etc.
Experience of Formulations development and adjuvants will be a plusMinimum of 2 years of team lead experience and/or people management experience in a global, matrix team.
Knowledge and understanding of product development processes, preferably in biologics, regulatory pathways for biologics (e.g. FDA, EMA), aptitude for troubleshoot analyses and experience of cGLP and cGMP.
Proven team building skills and strategic problem-solving ability. Ability to manage and lead others through change.
Demonstrated ability at managing matrix teams, influencing outcomes and key project decisions.
Inventprise is an equal-opportunity employer.
All qualified applications will receive consideration for employment without regard to race, age, gender, identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.
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