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Technical Manager / Product Owner

Company: GlaxoSmithKline
Location: Rockville
Posted on: September 12, 2020

Job Description:

Job description Site Name: USA - Maryland - Rockville

Posted Date: Aug 26 2020

Are you open to an amazing opportunity to lead tech transfer on an international level? If so, please read on:

This role will initially require approximately 50% international travel leading Technology Transfer to a Contract Manufacturing Organization (24 months).

Serve as GSK Technical Lead on manufacture of critical specialty products, including serving as technical lead / Person-In-Plant representing GSK at Contract Manufacturing Organizations (CMOs)

Support of product transfers from GSK sites to a CMO, between CMOs or from CMOs to GSK sites

Provide Pharma Supply Chain Technical input into developing product control strategy, author relevant sections of NDA/MAA, conduct OpTRA with contract manufacturers and ensure implementation of product control strategy on to shop floor/manufacturing operations.

Agree and enforce all Technical standards related to the manufacture and supply of GSK products by Contract Manufacturers, including new product introduction and validation of facilities, equipment and processes

Ensure that any issues related to product or process technology are identified, a root cause analysis conducted, and corrective actions implemented to ensure resolution

Maintain product robustness through continued process verification plan and periodic product reviews.

Support ongoing product supply by ensuring robust and capable processes are in place and monitored

Impact assessment and support of changes (GSK or CMO driven) including change control and risk assessment

Ensure with Quality Assurance that necessary validation activities have been planned and executed to current standards (e.g. Product Lifecycle Management) in line with GSK QMS

Lead technical risk assessment of new and existing products and facilities and identify/drive mitigation plans

Apply OE tools and principals in the implementation of technical projects and improvement initiatives

Work with multi-functional teams of Procurement, Quality, Technical, Supply, Project management, Strategy, Regulatory, Finance and Business Development professionals across the Global network.

Provide leadership of key improvement initiatives with GSK's partner organizations on delivery of objectives

Work to implement standards of quality by design into robust manufacturing operations

Represent Technical at CMC Steering Team and New Product Supply Board as required

Support mid-late phase portfolio projects and provide Pharma Supply Chain Technical input into design selection and manufacture considerations.

Support due diligence activities by providing technical assessment of potential new products/CMOs

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

BS in Chemical/Biochemical Engineering, Biochemistry, Chemistry or equivalent

10+ years experience in technical support of pharmaceutical manufacturing and/or process development

Excellent verbal and written communication skills

Ability to influence, lead and drive change

Demonstrated record of achievement, including ability to work effectively in cross-functional teams

Broad and integrated knowledge and experience that can impact project and team direction

Working knowledge of regulatory requirements in the industry and drug development

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

MS or PhD Chemical/Biochemical Engineering, Biochemistry, Chemistry or equivalent

Experience in technical support of commercial products, program management, technology transfer to commercial manufacturing sites (internal and to external CMO)

Experience in process validation, regulatory file preparation , PAI support

Technical support of product lifecycle activities (i.e. CPV, PPR, Change and Deviation Management)

Why GSK?

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 decision-making – using evidence and applying judgement to balance pace, rigour and risk

Managing individual and team performance.

Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.

Implementing change initiatives and leading change.

Sustaining energy and well-being, building resilience in teams.

Continuously looking for opportunities to learn, build skills and share learning both internally and externally.

Developing people and building a talent pipeline.

Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.

Building trust and collaboration, maintaining strong stakeholder relationships internally and externally.

Budgeting and forecasting, commercial and financial acumen.

*LI-GSK

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.

Full-Time, Rockville, Maryland, United States Technical Manager / Product Owner Full-Time, Rockville, Maryland, United States Start a career with purpose GSK is a place where outstanding people do amazing things. As a science-led global healthcare company, we exist to help people do more, feel better, live longer.

Annual bonus based on company performance

Long term incentives and pension plan

Learning and career development

Access to healthcare & wellbeing programmes

Keywords: GlaxoSmithKline, Rockville , Technical Manager / Product Owner, Other , Rockville, Maryland

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