NCBiotech
Sr. Engineer II, Mfg Sciences (Parenteral Filling)
NCBiotech, Durham, North Carolina, United States, 27703
About This Role
As a member of Manufacturing Sciences within the Parenteral Filling area, the Sr. Engineer II will provide technical expertise to the clinical and commercial manufacturing campaigns run at the Pharma Site. The focus of this position will be as a key leader for investigations and project implementation for Manufacturing Sciences using their technical expertise on fill/finish, visual inspection, and packaging.
What You'll Do
Provide technical expertise to the clinical stage, PPQ, and commercial manufacturing campaigns run at the site.
Lead Process & Technology Transfer teams, technical improvement projects, and technical process investigations as needed.
Provide technical and operational guidance to Manufacturing during GMP campaigns
Lead technical investigations towards process impact assessments and ensure timely completion and communication
Author Manufacturing and Process Performance Qualification validation protocols and technical reports.
Lead small teams on technical projects towards improved facility capabilities, efficient systems, improved technical competency, or increased process/scale-up understanding. Cultivate continuous improvement environment within the process transfer teams at the RTP site and benchmark tech transfer best practices both internal and external to Biogen, as appropriate.
Be the Subject Matter Expert to support inspections and audits.
Lead process investigations while servicing as the point of contact to broader organization.
Perform data analysis to support process improvements or process transfers. Manage technical projects providing value to the Pharma site.
Facilitate meetings with various stakeholders and communicate to management on the status of programs.
Who You Are You are a proactive and detail-oriented individual who thrives in a collaborative team environment. Your communication skills help you effectively lead technical projects and engage with cross-functional groups. You have a strong analytical mindset and are comfortable working with scientific datasets. Your independence and ability to manage multiple priorities make you an asset to the organization. You bring a keen understanding of industry standards and regulations, ensuring compliance and driving continuous improvement.
Requirements
Bachelors degree in Engineering or relevant scientific/technical discipline with at minimum 6 years of relevant experience is required
OR
Masters degree in Engineering or relevant scientific/technical discipline with at minimum 4 years of direct experience
OR
Ph.D. in Engineering or relevant scientific/technical discipline with at minimum 2 years of direct experience
Good communication and project management skills appropriate for leadership of tech transfer projects.
In-depth knowledge in technical understanding of Parenteral Filling Operations (e.g. Filling Isolator, Lyophilizer, Visual Inspection) including transfer of such processes into full-scale drug product manufacturing facilities.
Excel at working in a team environment
Comfortable analyzing scientific datasets/analytical skills with excellent written skills
Ability to work independently and support a large cross-functional group
Knowledge of cGMP, FDA/EMA regulations, Process Performance Qualification, Continued Process Verification
Ability to work weekends and be on call.
Job Level Management
Additional Information The base compensation range for this role is: $109,000.00-$146,000.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation
Why Biogen? We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
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What You'll Do
Provide technical expertise to the clinical stage, PPQ, and commercial manufacturing campaigns run at the site.
Lead Process & Technology Transfer teams, technical improvement projects, and technical process investigations as needed.
Provide technical and operational guidance to Manufacturing during GMP campaigns
Lead technical investigations towards process impact assessments and ensure timely completion and communication
Author Manufacturing and Process Performance Qualification validation protocols and technical reports.
Lead small teams on technical projects towards improved facility capabilities, efficient systems, improved technical competency, or increased process/scale-up understanding. Cultivate continuous improvement environment within the process transfer teams at the RTP site and benchmark tech transfer best practices both internal and external to Biogen, as appropriate.
Be the Subject Matter Expert to support inspections and audits.
Lead process investigations while servicing as the point of contact to broader organization.
Perform data analysis to support process improvements or process transfers. Manage technical projects providing value to the Pharma site.
Facilitate meetings with various stakeholders and communicate to management on the status of programs.
Who You Are You are a proactive and detail-oriented individual who thrives in a collaborative team environment. Your communication skills help you effectively lead technical projects and engage with cross-functional groups. You have a strong analytical mindset and are comfortable working with scientific datasets. Your independence and ability to manage multiple priorities make you an asset to the organization. You bring a keen understanding of industry standards and regulations, ensuring compliance and driving continuous improvement.
Requirements
Bachelors degree in Engineering or relevant scientific/technical discipline with at minimum 6 years of relevant experience is required
OR
Masters degree in Engineering or relevant scientific/technical discipline with at minimum 4 years of direct experience
OR
Ph.D. in Engineering or relevant scientific/technical discipline with at minimum 2 years of direct experience
Good communication and project management skills appropriate for leadership of tech transfer projects.
In-depth knowledge in technical understanding of Parenteral Filling Operations (e.g. Filling Isolator, Lyophilizer, Visual Inspection) including transfer of such processes into full-scale drug product manufacturing facilities.
Excel at working in a team environment
Comfortable analyzing scientific datasets/analytical skills with excellent written skills
Ability to work independently and support a large cross-functional group
Knowledge of cGMP, FDA/EMA regulations, Process Performance Qualification, Continued Process Verification
Ability to work weekends and be on call.
Job Level Management
Additional Information The base compensation range for this role is: $109,000.00-$146,000.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation
Why Biogen? We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
#J-18808-Ljbffr