Shire Cinryze Manager Manufacturing in Los Angeles, California

The Cinryze Manufacturing Manager is responsible for implementing all manufacturing related project milestones, assembling a team to support Developmental, Engineering, and Conformance runs as well as r the commercial production of CInryze and Baby Big. He/she is expected to ensure all manufacturing goals and project deadlines are met by the commitment dates while maintaining compliance with the current manufacturing practices (cGMPs), environmental health and safety (EHS) guidelines and any other regulations that could apply. He/she is expected to drive results to support plant strategic imperatives. He/she must enforce company rules and regulations and promote Shire Values within his/her shift. He/she is expected to coach/mentor employees to drive performance. He/she must be able to prepare and present technical reports and trends. He/she must have the ability to manage multiple priorities in a manufacturing plant setting, and prioritize responsibilities of self and direct reports appropriately. He/she must have organizational and administrative skills. He/she is expected to set the example for all other employees of Shire. Managers must promote the appropriate behavior, compliance, cleanliness, and culture of Shire.

Essential Duties and Responsibilities

  • Responsible for managing Cinryze production related activities to ensure the internalization project target goals and manufacturing goals are met.

  • Responsible for managing Baby Big production related activities to meet commitment dates as prescribed by the California Department of Health.

  • Ensure appropriate training for all employees on all shifts (including but not limited to cGMPs, job skills, safety, etc.) are completed.

  • Ensure assigned projects and deliverables (i.e. corrective actions, exception reports, meeting action items, etc.) are completed per the commitment date.

  • Drive the implementation of systems to maintain compliance with current good manufacturing practices (cGMPs), environmental health and safety (EHS) guidelines, FDA, and any other regulations that apply.

  • Ensure 100% compliance with established department procedures and regulations in producing high quality therapeutic products.

  • Drive performance with employees by providing a positive and equitable work environment emphasizing respect, responsiveness, and results, as well as, utilizing the talent management process.

  • Responsible for driving operational excellence and flawless execution in the areas of cost reduction, discard reduction, annual productivity improvements, inventory turnover, regulatory excellence including exception reduction and internal/external regulatory commitment management, on time delivery and lead time reduction, improving the overall safety of the work environment, leadership development and the ability to create a vibrant continuous improvement culture based on the principles of QLP, Lean Manufacturing, total employee involvement and DMAIC problem solving.

  • Lead/participate in site level EHS/engineering/quality/continuous improvement initiatives.

  • Additional duties as assigned.

Qualifications

  • Must have demonstrated interpersonal and leadership skills with the ability to interface well with personnel of all levels.

  • Must be able to work and facilitate a team-oriented environment.

  • Must have organizational and administrative skills.

  • Must have strong communication skills (both verbal and written).

  • Must be able to prepare and present technical reports and trends to management.

  • Must have ability to understand cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry.

  • Must have strong aptitude for operation and controls of manufacturing equipment and processes.

  • Must have experience with Microsoft Office applications.

  • May be required to supervise multiple groups.

  • Must have prior pharmaceutical manufacturing experience.

  • Ability to interpret and analyze statistical data and information and financial reports, understand and resolve technical difficulties, interface with internal engineering/technical experts and external technical representatives, manage multiple priorities in a manufacturing plant setting, be resourceful to a large manufacturing department.

Education and/or experience

  • Bachelor degree (science/technical/engineering discipline preferred)

  • 5-7 years related experience

  • Specialized knowledge in bio-pharmaceutical industry is preferred

Physical Demands

  • Must be able to lift, push, pull and carry up to 50 lbs.

  • In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.

Working Environment

  • Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.

  • No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.

  • Will work in a cold, wet environment.

  • Must be able to work multiple shifts, including weekends.

  • Must be able to work overtime as required. (only for non-exempt positions).

  • May be required to work in a confined area.

  • Some Clean Room and cool/hot storage conditions.

Equal Employment Opportunity

Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.