Assists in the direction of all facets of commercial and/or clinical scale production of recombinant proteins in Raheen.
As an Associate Director Biotech Production within Upstream Operations, a typical day may include, but is not limited to, the following:
Providing leadership, vision, and management to the commercial scale manufacturing team
Directing commercial scale manufacturing of recombinant proteins according to approved protocols, regulation, and schedule
Developing high level schedules, detailed production plans, and material requirements
Communicating with Supervisors/Managers on schedules and materials
Implementing new recombinant protein production processes transferred by the Tech transfer/Process Development team
Guiding Validation activities involving Manufacturing equipment and processes
Working cross-functionally with other departments, such as Facilities, Engineering, Process Development, Process Analytical Sciences, Regulatory, Quality Assurance and Quality Control
Formulating and recommending manufacturing policies, schedules, procedures and programs
Performing personnel management including scheduling of vacations, personnel development, and performance evaluations. Along with working closely with HR to ensure teams are resourced adequately
Leading routine meetings to supervise key manufacturing and support activities.
Recommending capital expenditures and aids in the realisation of capital projects
Ensuring safety standards are maintained
Tracking relevant technical and business process metrics to ensure operations are performing effectively and efficiently
Preparing and administrating expense and capital budgets
Performing cGMP audits of production area and represents manufacturing during regulatory and client audits
Developing and implementing comprehensive manufacturing activities reports
Reviewing, and/or approving Standard Operating Procedures, specifications, regulatory filing, or other controlled documents as needed
Leading and driving continuous improvement initiatives
This role might be for you if:
You have expert knowledge of Upstream Operations within Biopharma and have strong knowledge of industry practices and regulations.
You are a dedicated leader who can train, mentor and lead employees
You are a self-starter with the ability to operate in a multifaceted environment
You have the ability to maintain integrity and honesty at all times
To be considered for this position you must hold a BA/BS in any of the physical or biological sciences, or chemical engineering and 10+ years biopharmaceutical/biotech experience in a GMP production facility or equivalent combination of education and experience
#REGNIELSM #LI-Onsite #JOBSIEPR
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.