Bioprocess specialist

Job Description

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.


The Role

The Bioprocess Specialist- Drug Product reports to the Sterile Drug Product Operations Manager.


Main Responsibilities

1. 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.
2. 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.
3. 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.
4. Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance.
5. 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.
6. Participate in cross-functional teams, as applicable, to troubleshoot and resolve technical issues using root cause analysis tools.
7. Develop, define scope and support the implementation of technical solutions under the guidance of site change control systems.
8. Coach, mentor and train team members on area processes, procedures, use of operational excellence tools, and high performance team behaviors.
9. 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.
10. Supervise, and perform as needed, employee training in Sterile DP Manufacturing Operations.


Requirements


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



Communicates Effectively



Ensures Accountability



Drives Vision and Purpose



Interpersonal Effectiveness



Agility and Flexibility



Versatility



Results Oriented



High Ethical Standards and Integrity


Learning Orientation