Associate Director Process Engineering

Glaxosmithkline Waltham , MA 02154

Posted 2 weeks ago

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.

Specific Accountabilities:

  • 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.

Why you?

Basic Qualifications:

  • 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

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 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

  • #G

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.


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Associate Director CMC Small Technical Services And Engineering Oligonucleotide Engineering

Glaxosmithkline

Posted 2 weeks ago

VIEW JOBS 5/8/2020 12:00:00 AM 2020-08-06T00:00 Site Name: USA - Massachusetts - Waltham Posted Date: Jan 15 2020 Are you interested in influencing the development, implementation and management of robust, cost effective, and safe processes for the manufacture of oligonucleotide Active Pharmaceutical Ingredients (APIs)? This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: As the Associate Director, CMC Small Molecule Technical Services and Engineering (Oligonucleotide) you will be responsible for the technical development, support, innovative solutions and commercialization of oligonucleotide drug substances using an external network of providers. This position is integral to the advancement of GSK's growing portfolio of drug candidates and technology programs, and will provide technical oversite, expertise and guidance of externalized drug substance related activities. The scope of the role encompasses a wide breadth of lifecycle, ranging from early stage development, late stage development, process validation, early commercial manufacturing, contribution towards CMC content for regulatory submissions, regulatory approval and product life cycle management. The role will be critical in ensuring we optimize development, reduced risk profiles and ultimately accelerate the development cycle of assets. You will work within a cross-functional team environment of external service providers and internal team members to help define project scope and ensure successful delivery with regard to process improvements, technical troubleshooting, quality, timelines and budget. You will be responsible for building/maintaining strong working relationships with their respective staff and management. The successful candidate will report directly to the Senior Director, Technical Services and Engineering. Key Responsibilities: * Provide engineering leadership in support of oligonucleotide Active Pharmaceutical Ingredients (API) development programs. * Collaborate and coordinates in cross-functional teams, both internally and at CRO/CMOs, to develop robust, scalable, cost effective and safe processes. * Work closely with CMO production and maintenance for the evaluation, scale-up and implementation of new equipment and processes. * Develops, validates, and implements processes for Oligonucleotide Synthesis, Deprotection, Purification, and Isolation in a high throughput production environment. * Manage technology transfer of developed manufacturing processes to appropriate CRO/CMO facilities by ensuring the suitability of selected equipment trains and adaptation of process parameters. * Assist in due diligence efforts to assess technical capabilities for vendor selection and preparation of request for proposals. * Establish and maintain an understanding of current trends, emerging process technologies and ensure full awareness of current and emerging global capabilities for oligonucleotide production. * Recommend process improvements aimed at maximizing capacity utilization and reducing the cost of API production through process optimization; lead implementation at CRO/CMOs where appropriate. * Partner with project stakeholders to apply and execute Quality by Design (QbD) principles to define the design space and develop overall control strategy. Construct and manage controlled experiments to screen, optimize, and scale chromatographic and synthetic chemistry processes. * Troubleshoot new and existing product or process issues related to yield, quality and throughput, utilizing structured problem-solving techniques and quality assurance mechanisms when appropriate. * Develop assessments and strategies for identifying, managing, and reducing product / process risk utilizing a variety of techniques including Technical Risk Assessments, FMEAs, DOEs and Control Plans. * Develop technical summaries and provide assistance for regulatory filings. * Analyze process test results, issue reports and make technical recommendations. * Presents results and progress of CMC programs to internal and external audiences as appropriate. * Manage process capability in respect to the overall needs of the project(s), driving a solutions based approach to address yield and quality issues in a regulated production environment. * Create, review and approve technical documents including batch records, engineering / development reports, and risk / validation assessments. Why you? Basic Qualifications * Ph.D. in bio/chemical engineering, chemistry, biochemistry (or other relevant physical or life sciences discipline) with 10+ years of experience in oligonucleotide drug development biotech or pharma industry, with significant experience in the areas of isolation, purification, process characterization, process validation and product life cycle management or BS/MS with equivalent education or experience is required. * Demonstrated history working in a virtual CMC development/commercialization environment working with CMC partnerships with global providers. * Thorough understanding of oligonucleotide chemistry, including phosphoramdite based synthesis methods, deprotection, purification and isolation methods. * Proficiency in automated oligonucleotide synthesis equipment. * Experience in oligonucleotide analytical / quality control. * Ability to travel, 20%- 30%(domestic and international). Preferred Qualifications * Ability to work in a fast-paced and dynamic corporate environment with changing priorities, and flexibility to support multiple programs simultaneously. * Ability to work under pressure, meeting time sensitive deadlines, while maintaining a high level of confidentiality. * Ability to problem solve using innovative thinking and good decision making. * Ability to innovate, implement change and drive for results. * Strong collaboration and communication skills; ability to build and maintain good working relationships with internal and external stakeholders. * 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. * Personal attributes: self-starter; attentive to details; results oriented; accountable; committed while maintaining balance and perspective. Others will describe you as honest, trustworthy, and respectful of others; a person of high integrity, a good listener, a straightforward communicator, and a team builder. 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: * Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. * Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. * Continuously looking for opportunities to learn, build skills and share learning. * Sustaining energy and well-being. * Building strong relationships and collaboration, honest and open conversations. * Budgeting and cost-consciousness. * 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/Affirmative Action Employer. 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. Glaxosmithkline Waltham MA

Associate Director Process Engineering

Glaxosmithkline