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Manager, Manufacturing Drug Substance

Company: Boehringer Ingelheim
Location: Fremont
Posted on: June 17, 2022

Job Description:

Description:Description\:This Job Profile encompasses the Manager roles for Upstream and Downstream Drug Substance Operations. The scope of upstream includes all or a portion of the following scope\: The skills, knowledge, abilities and education necessary to manage Cell Inoculum, Material Management, Cell Culture (100L - Harvest).The scope of the downstream includes all or a portion of the following scope\: The skills, knowledge, abilities, and education necessary to manage Harvest Operations (2k), Initial Purification, Final Purification, Formulation, Bulk Filtration and Freezing operations.The manager is responsible to ensure compliance of the Manufacturing Processes in accordance with cGMP regulations within their area of expertise. They are also responsible to implement, maintain and monitor all quality processes necessary for that assurance. This includes implementing and supervising all activities in the assigned work area to ensure manufacturing goals and project deadlines are met while maintaining compliance with current good manufacturing practices (cGMPs), environmental health and safety (EHS) guidelines and any other regulations and ensures a safe work environment while coaching/supervising direct reports.The Drug Substance Manager leads and provides direction for a manufacturing team consisting of 6 - 10 people. The manager is responsible for the success of BI products (Biosimilars and NBEs- New Biological Entities) as well as CMB (customer manufacturing business) drug substance in the Fremont multi-product facility.The Manager provides technical expertise on standards and processes, creates a work environment that is collaborative and has a continuous improvement mindset. They initiate, implement and maintain more department programs intended to improve safety, quality, compliance and staff engagement such as\: department recognition programs, safety improvement programs, standard work programs, training development programs, human factor reduction programs. They lead manufacturing programs for the entire manufacturing organization (cell culture or purification).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 the work of their shift to meet productivity and efficiency goals to achieve operation and quality goals and objectives. Provides technical leadership in manufacturing operations.
    • Interview, hire, train, supervise, coach, motivate and develop staff.
    • Responsible for coordinating the day-to-day activities and managing their staff.
    • Monitor and communicate staffing needs based on production schedule.
    • Determines staff assignments on a daily basis.
    • Defines performance objectives and nurtures the development plans of their staff members.
    • Ensures team members are contemporaneously documenting manufacturing operations in batch records. The manager ensures that the batch record performance targets are achieved including but not limited to continuous reduction of batch record errors, reduction of the necessity to document clarifying comments and improvements in legibility. The manager ensures systems are in place to review completeness of batch documentation at the end of every shift.
    • Ensures safety standards, procedures and processes are followed by the staff on the production floor. Identifies, initiates, and completes projects which improve safety on the shop floor. Regularly communicates to shift and support functions the importance of safety and thoroughly investigates near miss safety events. Ensures that safety improvements are robustly implemented and determines if further actions are required to mitigate future near miss events.
    • Ensure the members of the shift comply with internal procedures and processes and that the members of the shift take action to improve compliance. Measure shift performance against quality and compliance targets.
    • The manager is the manufacturing point of contact for audits and inspections with the area for which they directly control. The manager leads his/her team to perform housekeeping walks directly in advance of audits. The manager practices tours and prepares his/her staff to succinctly and accurately answer auditors' questions.
    • Ensure shift is adequately trained to perform manufacturing operations\:
      • Ensure shift has a sufficient number of staff to perform each operational step.
      • Ensure shift trainer emphasizes safety, quality and compliance.
      • Ensure program is technically sound and emphasizes the underlying science of the operational steps and the potential error traps to avoid.
      • Implement programs to track errors, identify improvement opportunities and implement activities to improve training.
      • Works with the leadership team to define annual manufacturing strategy and objectives. Translates the business strategy into objectives and goals for the department, not just his/her shift.
      • Collaborates within department and cross functionally to meet set objectives. Represents cell culture/ purification on cross functional teams and gains alignment on day-to-day issues and needs. Identifies, initiates, and completes projects which improve operational excellence on the shop floor.
      • Spearheads one or more department wide programs intended to improve safety, quality, compliance and staff engagement such as\: department recognition programs, safety improvement programs, standard work programs, training development programs, human factor reduction programs.Requirements\:
        • High School Diploma with ten (10) years of cGMP industry experience, three (3) of which are in a supervisory role; OR
        • Associate's Degree from an accredited institution, preferably in a science or engineering related field, with eight (8) years of industry experience, three (3) of which are in supervisory role; OR
        • Bachelors Degree from an accredited institution, preferably in a science or engineering related field, with five (5) years of industry experience, three (3) of which are in a supervisory role.
        • Requires three (3) years or supervisory experience in a cGMP pharmaceutical manufacturing environment leading teams in a cGMP pharmaceutical manufacturing environment or equivalent experience.
        • Experience interviewing, hiring, training, supervising, coaching, motivating, developing and disciplining Manufacturing Staff.
        • Experience coordinating the day-to-day activities, overseeing manufacturing teams, manufacturing investigations/CAPAs, performing FMEA & gap assessments and production planning/scheduling concepts.
        • Requires intermediate understanding of biopharmaceutical manufacturing, resource planning, performance management and coaching concepts.
        • Requires prior demonstrated supervisory competencies and strong interpersonal skills.
        • Excellent oral communication skills
        • Must be able to motivate and mobilize staff
        • Must exercise rapid learning ability, attention to detail, excellent computer 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.
        • Must have well-developed interpersonal skills with the ability to establish highly functional relationships with diverse personalities both within and outside the manufacturing.
        • Demonstrated proficiency in MS Office programs and associated computer programs.
        • Must be able to work in a team environment.
        • Leadership\:
        • Requires interpersonal, investigative and implementation skills.
        • Demonstrated influencing, relationship building, and effective facilitation.
        • Excellent communication skills with the ability to Influence Cross functionally.
        • Ability to handle multi tasks and provide the leadership and strategy to a team.
        • Technical\:
        • Expertise in biopharmaceutical manufacturing practices, quality processes, compliance management and the data trending principles.
        • Experience in leading continuous improvement initiatives.
        • Some experience in strategic planning for continuous improvement.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 older.
          • This position will require individuals to be fully vaccinated against COVID-19 or have an approved medical or religious accommodation. Click here for more information on the vaccine mandate and COVID-19.Who 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 and join us in our effort to make more health.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. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

Keywords: Boehringer Ingelheim, Fremont , Manager, Manufacturing Drug Substance, Executive , Fremont, California

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