Site Name: USA - Massachusetts - Waltham
Posted Date: Apr 21 2020
Associate Director, Process Engineering
The Associate Director, Process Engineering will join a cross-functional team of scientists/engineers responsible for the process development and manufacturing of biologics programs within the Strategic Externalization Development organization.
DUTIES & RESPONSIBILITIES:
Provide scientific and engineering leadership in supporting process tech transfer and GMP manufacturing of biologics drug substance.
Oversee biologics drug substance manufacturing process tech transfer and scale-up; continuously scrutinize biologics drug substance manufacturing operations to identify, assess, and implement opportunities for process improvement.
As a technical lead and subject-matter expert (SME) for onsite GMP manufacturing support, collaborate with applicable functional area personnel, assess and resolve technical issues that arise during biologics drug substance manufacturing operations.
Serve as a subject-matter expert on process engineering support during regulatory agency inspections.
Serve as SME for department and company on the development or evaluation of technical concepts and methodologies, new unit operations, data analysis techniques and tools, risk management evaluations/assessments.
Lead process automation and equipment validation activities as related to biologics drug substance manufacturing.
Review and approve applicable product batch documentation, including batch records, testing data, change controls and deviations
Collaborate with internal stakeholders and smoothly transition commercial manufacturing responsibility to internal commercial manufacturing organization.
Abilities Needed for Success
Proven ability to work with a high level of integrity, accuracy, and attention to detail
Strong technical/analytical skills to identify and solve problems.
Self-motivated, assertive, and self-confident with the ability to act with urgency and passion.
Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting in order to complete assignments on-time and on-budget.
Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company.
Ability to make thoughtful, integrated, timely and meaningful decisions and take corresponding actions.
Willingness to work collaboratively by incorporating diverse perspectives and appropriately managing relationships in order to strengthen decision-making.
Proactively seeks out and recommends process improvements.
Entrepreneurial, enjoys working in a fast-paced, small-company environment.
Flexibility in handling work flow in a multi-tasking environment.
Ability to work under pressure, meeting time sensitive deadlines, while maintaining a high level of confidentiality.
Provide technical leadership, management and oversight for:.
Tech transfer, scale-up and manufacture of biologics drug substance to support nonclinical studies and clinical evaluation.
Prepare CMC documentation for regulatory and/or patent filings.
Collaborate with internal stakeholders and external business partners to achieve group, departmental and corporate goals.
Establish and maintain an understanding of current trends and emerging process technologies to ensure that team is at the forefront of biologics development.
Apply innovative technical ability and knowledge to critically analyze experimental data and results.
Set clearly defined goals/objectives to ensure delivery of high-quality results.
Provide clear communication to core teams and functional line management regarding progress against technical objectives/milestones.
Ensure well-organized, clear and complete records of all activities across areas of responsibility.
Develop and maintain SOPs, policies and guidance documents relevant to areas of responsibility.
Manage and execute personnel qualification/training program.
Minimum of 10 years of experience in biologics drug substance development in biotech or pharmaceutical industry with significant experience in the areas of cell culture, protein expression, isolation, purification and characterization.
Bachelor's degree in an Engineering, Chemistry, or equivalent discipline required (PhD or Master's degree in an appropriate technical discipline desired)
Strong knowledge of biologics manufacturing required
Position will require this person to be on-site at our CMOs during critical processing operations.
Domestic / international travel up to 25%
Demonstrated project management capability
Proficiency with MS Office applications; advanced knowledge of Excel and MS Project desired
Excellent written and oral communication skills, including the maintenance of technical data and reports; proactive collaboration a multi-disciplinary business and science team environment is essential
Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk, governance and control, managing ambiguity and paradox.
Managing individual performance.
Creating a performance culture and driving results, prioritisation, execution, delivering performance.
Setting strategic direction and leading on-going organisational transformation.
Building a resilient organisation. Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit.
Managing P&L and capital allocation
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