BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients' lives.
The Role: The Bioprocess Specialist- Drug Product reports to the Sterile Drug Product Operations Manager.
Role Summary The Bioprocess Specialist will work in a team environment that will be committed to continuous improvement, process understanding, personal development, and demonstration of production techniques that will result in agile and compliant manufacture of Drug Product material.
Duties The Bioprocess Specialist will work in a team environment that will be committed to continuous improvement, process understanding, personal development, and demonstration of production techniques that will result in agile and compliant manufacture of Drug Product material.
Main areas of responsibility: Support and partner closely with peer groups to ensure master batch records, SOPs, training records and other documents are current and compliant under cGMP conditions – ensure Manufacturing systems and practices are consistent throughout the organization.Own, investigate, write and approve associated deviations as well as support & coach Biotechnicians in these functions – ensure adoption of 'zero late' mentality in meeting timelines.Ensure areas meet compliance standards and audit areas against standards - highlight any issues and work proactively with the area team and others to ensure resolution.Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance.Partner with validation subject matter experts, prepare/approve validation protocols, validation plans, protocol executions, and summary reports in support of ongoing revalidation and validation efforts required for commercial manufacturing.Participate in cross-functional teams, as applicable, to troubleshoot and resolve technical issues using root cause analysis tools.Develop, define scope and support the implementation of technical solutions under the guidance of site change control systems.Coach, mentor and train team members on area processes, procedures, use of operational excellence tools, and high performance team behaviors.Effectively and consistently prioritize and delegate daily assignments and projects to technicians and associates. Ensure that all staff understand, properly prioritize, and execute their assignments and adhere to production schedule.Supervise, and perform as needed, employee training in Sterile DP Manufacturing Operations.Skills Demonstrated experience working with NPI processes in manufacturing environment.Past experience and proven track record to successfully influence team performance.Strong demonstrated ability in the area of communication and strong ability to interact across cross-functional teams.Demonstrated ability to train and coach colleagues in processing, operational excellence, team interactions and delivering results.Experience with regulatory inspections.EQUIPMENT Should be proficient in the operation of all equipment used in the respective functional area of responsibility.
Education Required Degree in Science / Engineering, Operations Management, or Industrial Engineering required.Other continuing education initiatives highly desirable (e.g. Six Sigma, Lean Manufacturing, industry specific coursework).Experience Required At least 3 years of related experience in a regulated manufacturing environment with excellent knowledge of aseptic controls.Experience in drug product filling, packaging and labeling beneficial.Demonstrated ability to partner with other functional groups to achieve business objectives.Strong knowledge of cGMPs (US & EU), OSHA, ISO, and other regulatory agency standards and requirements applicable to a pharmaceutical production facility.Experience of successfully contributing to a start-up operation highly desirable.Strong communication and interpersonal skills – Oral, written and formal presentation skills.Creative problem-solving skills.Leadership Behaviors and Personal Competencies: Collaboration Builds partnerships and works collaboratively with others to meet shared objectives.Communicates Effectively Develops and delivers communications which convey a clear understanding of the unique needs of different audiences;Skilled influencer; able to distill complex concepts into concise, salient points.Ensures Accountability Holds self and others accountable to meet commitments by following through, acting with a clear sense of ownership, and taking personal responsibility for decisions, actions and failures.Drives Vision and Purpose Presents a compelling picture of the vision and strategy which motivates others to action.Interpersonal Effectiveness Credible, trustworthy and empathetic leader; calm under pressure; can do attitude; relates openly and comfortably with diverse groups of people.Agility and Flexibility Handles multiple projects and priorities simultaneously; operates effectively, even when things are not certain or the way forward is unclear.Versatility Able to work in a variety of roles and settings, with a diverse group of people and/or functions.Results Oriented Able to prioritize and focus on the few critical objectives;Design simple, flexible organizational structures and systems that can align and adapt with evolving strategy.High Ethical Standards and Integrity Learning Orientation Effectively adjusts to new, changing and unpredictable situations; able to learn new things quickly and easily; solicits and responds to feedback and coaching. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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