Director Process Development Purification Process West Greenwich, RI
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Job Location:
West Greenwich, RI - USA
Monthly Salary:
Not Disclosed
Posted on:
18 hours ago
Vacancies:
1 Vacancy
Job Summary
ATTENTION MILITARY AFFILIATED JOB SEEKERS- Our organization works with partner companies to source qualified talent for their open roles. The following position is available toVeterans Transitioning Military National Guard and Reserve Members Military Spouses Wounded Warriors and their Caregivers. If you have the required skill set education requirements and experience please click the submit button and follow the next steps. Unless specifically stated otherwise this role is On-Site at the location detailed in the job post.
Director Process Development - Purification Process Engineering
What you will do
Lets do this. Lets change the this vital role you will lead the Purification Process Engineering function within Process development this role you will be responsible for technical guidance of commercial Drug Substance operations within a high mix multiproduct manufacturing facility. This includes technical transfer and scale up of processes deployment of novel manufacturing technologies and troubleshooting biologics manufacturing processes.
The successful candidate will serve as the primary process development point of contact with key leadership partners in Manufacturing and Quality. This leader will ensure that process engineering deliverables including new process introduction; implementation of new technologies; Process Performance Qualification (PPQ) and ongoing monitoring and support of drug substance production are managed and completed. They will have an entrepreneurial approach with ambition to drive innovation and plant efficiency through exploration of process technology and capacity improvement opportunities. The Director ensures groups outputs are safe compliant and aligned with plant performance goals.
Additional Responsibilities:
Provide leadership and subject matter expertise in bioprocess purification disciplines including chromatography and filtration operations. Good knowledge of quality regulatory and development requirements for large molecule manufacturing.
Support process scale-up and technology transfer to production facilities. Partners closely with development teams to ensure successful transfer of knowledge to process teams during technical transfers.
Lead a successful team committed to finding innovative ways to maximize team engagement and ensure the team reaches its full potential.
Lead multi-functional teams to resolve complex technical problems while meeting quality schedule and cost objectives.
Serve as member of Drug Substance Technology extended leadership team and utilize network thinking and advancing the process development function.
Engage with the manufacturing and process development network to assess technology and to improve facility capacity and capability.
Director Process Development - Purification Process Engineering
What you will do
Lets do this. Lets change the this vital role you will lead the Purification Process Engineering function within Process development this role you will be responsible for technical guidance of commercial Drug Substance operations within a high mix multiproduct manufacturing facility. This includes technical transfer and scale up of processes deployment of novel manufacturing technologies and troubleshooting biologics manufacturing processes.
The successful candidate will serve as the primary process development point of contact with key leadership partners in Manufacturing and Quality. This leader will ensure that process engineering deliverables including new process introduction; implementation of new technologies; Process Performance Qualification (PPQ) and ongoing monitoring and support of drug substance production are managed and completed. They will have an entrepreneurial approach with ambition to drive innovation and plant efficiency through exploration of process technology and capacity improvement opportunities. The Director ensures groups outputs are safe compliant and aligned with plant performance goals.
Additional Responsibilities:
Provide leadership and subject matter expertise in bioprocess purification disciplines including chromatography and filtration operations. Good knowledge of quality regulatory and development requirements for large molecule manufacturing.
Support process scale-up and technology transfer to production facilities. Partners closely with development teams to ensure successful transfer of knowledge to process teams during technical transfers.
Lead a successful team committed to finding innovative ways to maximize team engagement and ensure the team reaches its full potential.
Lead multi-functional teams to resolve complex technical problems while meeting quality schedule and cost objectives.
Serve as member of Drug Substance Technology extended leadership team and utilize network thinking and advancing the process development function.
Engage with the manufacturing and process development network to assess technology and to improve facility capacity and capability.
Additional Qualifications/Responsibilities
What we expect of you
We are all different yet we all use our unique contributions to serve patients. The dedicated professional we seek is a leader with these qualifications.
Basic Qualifications:
Bachelors degree and 10 years of Process Development Engineering or Manufacturing experience OR
Masters degree and 8 years of Process Development Engineering or Manufacturing experience OR
Doctorate degree and 4 years of Process Development Engineering or Manufacturing experience
In addition to meeting at least one of the above requirements you must have at least 4 years experience directly managing people and/or leadership experience leading teams projects programs or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above
Preferred Qualifications:
MS degree in Chemistry Biochemistry Biochemical or Chemical Engineering or in a technological field. 10 years of experience in pharmaceutical/biopharmaceutical process development or process support and current in Good Manufacturing Practices (cGMP) and global regulatory expectations
Ability in providing scientific and engineering expertise to multi-functional teams in manufacturing quality and supply chain to advance complex projects to completion and to interface on technical problem resolution
Ability to compile and statistically analyze data draw appropriate conclusions and make presentations to multi-functional audience and senior management
Detailed understanding of all stages of Process Validation lifecycle in biologics: Process Design PPQ Continued Process Verification (CPV)
Understanding of quality attributes of large molecules and protein products and analytical methods for determination of these attributes
Demonstrated skills in leadership negotiation and managing customer expectations
What you can expect of us
As we work to develop treatments that take care of others we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture well support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to relevant skills experience and qualifications.
In addition to the base salary Amgen offers a Total Rewards Plan based on eligibility comprising of health and welfare plans for staff and eligible dependents financial plans with opportunities to save towards retirement or other goals work/life balance and career development opportunities that may include:
A comprehensive employee benefits package including a Retirement and Savings Plan with generous company contributions group medical dental and vision coverage life and disability insurance and flexible spending accounts
A discretionary annual bonus program or for field sales representatives a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Required Experience:
Director
Key Skills
- Accomodation
- Building Services
- CNC
- Corporate Risk Management
- Linux
- Asic
About Company
VetJobs & Military Spouse Jobs works with our employer partners to source, screen, and move qualified talent to the desktops of the Hiring Managers. Application is a two-step process, so please be patient with the team. When you submit to a position on our site your information will ... View more
