Job Description - Associate Director, Process Engineering-Downstream (193657)Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture.
We embrace diversity of perspectives and strive for an inclusive environment which benefits our employees, patients and communities.
Associate Director, Process Engineering-Downstream-193657 Boehringer Ingelheim Fremont is the rapidly growing US arm of Boehringer Ingelheim’s Biologics Business Unit.
We are a fully integrated biologics operation with over 500 scientist and specialists, covering cutting edge early- to late stage CMC development, clinical and commercial drug substance and drug product manufacturing, medical device assembly for combination products and packaging operations.
We are continuing our rapid growth, investing over $200m into the expansion of our capacity and capabilities, and creating approximately 200 new jobs.
Driving this growth is an exciting pipeline of multiple Boehringer Ingelheim novel biologic entities (NBEs) and biosimilars, as well as, a growing diverse portfolio of therapeutics we develop and manufacture for other leading pharma and biotech companies.
This includes multiple commercial product launches planned over the next couple of years, for which we can tap into Boehringer Ingelheim’s unique experience of having brought 30 biologics to market globally.Leveraging our diverse talent pool, we are also driving technology and innovation globally, through major investment and collaborations into next generation manufacturing platforms and technologies, which may change how biologics will be made in the future.Whether we work on our own products, help partners to bring their products to market or innovate new technologies and approaches - Everything we do, we do to help patients Description: Leads, drives and manages the Downstream Process Engineering group at BI Fremont.
This position is responsible to execute process transfers to GMP facilities for manufacturing of biopharmaceutical drug substances.
This includes process transfers of BI products as well as CMB (customer manufacturing business) products in the Fremont multi-product facility.
This position provides scientific, technological support during process transfers, launch, and initial supply, including trouble shooting and continuous process improvements in a highly complex environment.
This position manages technical interfaces with external clients and BI internal units as well as BIFI internal.
Being the technical interface between customer/process sciences upstream and cell culture manufacturing this role supports that GMP/regulatory requirements are met.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers.
Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success.
We realize that our strength and competitive advantage lie with our people.
We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance.
Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities: Leads, drives and manages Downstream Process Engineering team in alignment with the strategic direction of Fremont Manufacturing in a rapidly growing, highly dynamic environment.Motivates, retains and develops key employees.
Build and sustaining employee engagement by creating an environment where individuals and teams can excelProvides effective leadership according to the BI leadership principles including: developing and implementing objectives and business strategies; selecting key personnel and motivating members of the functional area; challenging employees to develop as leaders while serving as a role model and mentor; assisting with performance calibration/talent pool management/succession planning; individual goal setting/performance reviews; training and development; supporting workforce diversity, quality and safety and supporting managers/leads in the management of their employees which support achievement of individual/department/business objectivesEnsures effective utilization of resources by creating robust employee development, performance management, succession planning, and rewards and recognitions practices within manufacturingResponsible for Process transfers including of the respective discipline:Performs process/tech-transfer for assigned projects and supervise projects over time till commercial phase.Provides scientific and technical guidance in process transfersProvides supervision to junior process engineersCollaborates with other team members in cross-functional transfer teams, with international customers and lead of BI sub-teams.Responsible for performing the process evaluation and facility fit including materials, and identifying required equipment for new processes to be implemented in the GMP-Manufacturing facility.Performs scale-up with adaptations and process improvements if required to ensure optimal process design for maximal facility output.Plans process-transfer activities according to timeline and qualityManages technical interfaces with national and international clients and BI internal units (Process Science, Quality Assurance and Control, Supply Chain Management, Engineering and Technology, Project Management, Manufacturing, etc.).
Discusses and present results to internal or external customers to successfully transfer processes.
Involved in writing of Summary Reports.Designs and planning of small-scale studies in collaboration with Process Science during transfer-runsPerforms technical assessments for different purposes e.g.
deviations.Supports the New Product Implementation (NPI) process including technical FMEA risk assessments MFG Point of contact for overall process validation planning and execution.Involved in the writing and review of specific sections of CMC dossiers (IND`s, BLA`s).Supports and reviews Requests for Proposals from potential customersScientific lead in trouble shooting activities to support manufacturing (e.g., technical, equipment, and process performance issues, including planning of small-scale testing in collaboration with PS) during process transfer activities or investigations for deviations.Ensures that investigations are consistent with manufacturing practices (process and methods), policies and complying with external regulatory requirements.Supports BIFI BPE continuous improvement initiative.Identify, plan and execute process improvements to increase robustness, productivity and efficiency.Identifies and establishes state-of-the-art technologies for large manufacturing operations.Requirements:Bachelors’ degree from an accredited institution with a minimum of eight (8) years direct experience.
A Masters’ degree will be considered with four (4) years direct experienceExperience must include four (4) years prior management experience and industry experience in protein purification, protein chemistry, tech transfer and bioengineering.
Operational experience in Biotech drug substance manufacturing.
In depth knowledge of cGMP`s and quality systems, in-depth project management experiences in CMC Also preferable experience in Bioengineering Technology, Manufacturing and Business Process Excellence tools (Six Sigma), Project Management skills, and general management skillsWorking knowledge of applicable Regulatory requirements (cGMP, DEA, OSHA, BOCA, EPA) and contract lawSelf-directed leadership abilityExcellent oral and written communication skills Must exercise rapid learning ability, attention to detail, excellent computer skills, excellent communication skills, team player, organized analytical thinker with a high level of energy and self-motivation.
Ability to read, develop and understand procedures and other controlled documents Must have excellent written and verbal communication skills, including technical writing.Must have well-developed interpersonal skills with the ability to establish highly functional relationships with diverse personalities both within and outside the company.
Intermediate MS Outlook, Word and Excel skills.Physical Demands / Surroundings – Works primarily in an office setting under desirable conditions with few or no disagreeable features.
Duties do not require incumbent to exert physical effort beyond normal office conditions.
The individual may be required to enter and perform work in the manufacturing areas.
This may include periods of frequent standing or working.
Some domestic and international travel required.Visual Demands - Must be able to read and see clearly.
Vision clarity with or without correction to read handwritten as well as computer generated documents.Attendance / Schedule - Attendance requirements are based on general attendance policies and the needs of the business as set forth by direct manager.Eligibility Requirements: Must be legally authorized to work in the United States without restriction.Must be willing to take a drug test and post-offer physical (if required)Must be 18 years of age or olderWho We Are:At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients.
We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals.
As a family owned company we focus on long term performance.
We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture.
Learning and development for all employees is key because your growth is our growth.Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA Inc., Boehringer Ingelheim Animal Health Puerto Rico LLC, and Boehringer Ingelheim Fremont, Inc.
is an equal opportunity and affirmative action employer committed to a culturally diverse workforce.
All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by applicable law.
LI-SS1 Job - BiopharmaceuticalsPrimary Location - Americas-US-CA-FremontOrganization - US-BI FremontSchedule - Full-time