Sr Manager Upstream Process Technology MSAT
Sr Manager Upstream Process Technology MSAT
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1 Vacancy
Job Description
About This Role
As Sr. Manager Upstream Process Technology you will join the Global Manufacturing Sciences Department at the Solothurn drug substance biologics manufacturing site to oversee all USP Process Transfer & Sciences activities. You will lead crossfunctional teams to facilitate new product introduction process transfers validation and advance process technologies. You will oversee technical support for manufacturing campaigns and provide leadership in addressing process deviations & change controls.
As part of a talented team of Process Engineers & Scientists you will coordinate daily activities & provide scientific leadership for lab studies to advance process understanding support investigations & drive process improvements. You will author and review technical documents lead engagements during regulatory audits & filings and communicate project & technical issues.
What Youll Do
- Key technical leader in USP process technologies accountable for coordination of technical and laboratory activities in support of technology transfer continued cGMP manufacturing & process improvements.
- Provide guidance and coordinates USP Process Transfer & Sciences SME activities incl. GMS lab operations & studies. Establish efficient workflows.
- Lead crossfunctional project teams to enable process transfer validation & process life cycle activities.
- Accountable for technical manufacturing support through process monitoring resolution of technical issues & participation in operations governance huddles.
- Lead technical process investigations rootcause analysis and definition of appropriate corrective measures & effectiveness checks. Author and assess change controls.
- Author technical protocols/reports for process performance qualification continued process verification investigations and regulatory submissions.
- Trend & analyze process data to guide & implement advancements of USP process technologies process robustness & productivity initiatives.
- Communicate project/campaign/technical status to stakeholders and leadership while assuring alignment with strategic goals and site priorities.
Who You Are
You are a highly experienced technical expert in upstream drug substance manufacturing operations and process sciences. You excel in coordinating technical expertise and leading crossfunctional project teams to align with strategic goals and site priorities. You think broadly considering the bigger picture while navigating complex challenges and you drive results by ensuring that every action contributes to achieving measurable outcomes. You are selfdriven with the desire to make a positive impact on peers processes and patients.
Qualifications :
Required Skills
- Bachelors degree in a relevant technical discipline with a minimum of 10 years of relevant experience.
- Masters degree in a relevant technical discipline with a minimum of 8 years of relevant experience.
- PhD in a relevant technical discipline with a minimum of 4 years of relevant experience in MSAT.
- Extensive experience in manufacturing operations within pharmaceutical or biotech facilities with a strong background in cell culture technology.
- Indepth technical expertise in advanced upstream bioprocess technologies including Process Analytical Technology (PAT) and manufacturing operations.
- Demonstrated project management experience with a proven ability to lead and collaborate effectively within a team environment.
- People management experience.
- Good interpersonal skills with the ability to influence behaviors negotiate and resolve challenges with poise tact and diplomacy.
- Strong data analysis technical writing presentation and communication skills.
- Practical knowledge and application of cGMP and FDA/EMA compliance regulations and inspections with experience interfacing with inspectors and/or agency personnel.
Additional Information :
Why Biogen
We are a global team with a commitment to excellence and a pioneering spirit. As a midsized biotechnology company we provide the stability and resources of a wellestablished 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 lifechanging 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.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
