Senior Principal Scientist Process Modeling Lead

Job Description

Why Patients Need YouPfizer s purpose is to deliver breakthroughs that change patients lives. Research and Development is at the heart of fulfilling Pfizer s purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will applycutting edge design and process development capabilities to accelerate and bring the best-in-class medicines to patients around the world. What You Will AchieveWhen you join Pfizer,youll be joining a company and team with a desire to bring new, cutting-edge medicines to patients around the world. As a member of our team, youll use science and technology to design, characterize and develop the solid form of active pharmaceutical ingredients (API) and drug product formulations from discovery to commercial launch. You will be able to leverage your existing scientific knowledge, as well as develop in new areas, to evaluate the chemical & physical stability, bio-performance and manufacturability of the drug product across a diverse range of therapeutic areas.As a Senior Principal Scientist, you will be at the center of our operations andyou ll find that everything we do, every day, is in line with an unwavering commitment to quality. You will be recognized as an outstanding scientist in your group. With your advanced knowledge of the discipline, you will regularly contribute in multi-disciplinary teams representing the department and influencing cross-functional teams. Your innovation is seen in way you promote the use of novel experimental approaches, create processes, hypotheses and methodologies. You will be using your scientific judgment to adapt standard methods and techniques by applying prior work experience. You will be entrusted withidentifying and developing scientific strategies to support scientific goals and set the direction for business unit projects. You will undertake mentoring activities to guide team members.Through yourexpertise and extensive knowledge, you will be able to foster a culture that promotes innovation and thrives on doing better for patients and healthcare.How You Will Achieve It

• Apply technical and functional knowledge to design and independently execute experiments/projects, contributing to the overall direction of project.
• Act as a scientific resource within own sub-function/therapeutic area/discipline.
• Work with key stakeholders in Medicinal Sciences, Commercial, Clinical, Pfizer Global Supply (PGS) and other partner lines to define the product concept and lead the operational planning for projects.
• Provide clinical research pharmacy expertise in the development and management of investigational products at a program and protocol level (i.e. investigational product handling manuals/pharmacy manuals for utilization by clinical sites).
• Provide clinical pharmacy expertise in the development and management of investigational product handling manuals/pharmacy manuals for utilization by clinical sites.
• Educate clinical site personnel through in-services, investigator meetings and clinical site initiations or follow-up visits on the proper handling and use ofinvestigational products.
• Work closely with the Category Lead in the relevant therapeutic area to ensure the strategy being developed for each asset is communicated and represented clearly.
• Provide consultation to clinical project teams on medication/device related issues, such as concomitant medications, exclusionary medications and patient compliance/adherence issues.
• Lead multi-disciplinary initiative teams in the development and implementation of innovative products and processes tooptimizeinvestigational product use.
• Provide guidance to team members and customers regarding operatingunits and research functions.
• Mentor/lead/manage other research pharmacy team members.

QualificationsMust-Have

• Doctoral Degree (PhD/PharmD) and 8 years of experience.
• Demonstrated influencing and negotiatingskills and proven skills in developing others within their own functional area.
• Strong skills in planning, scheduling, forecasting, including the use of relevant IT tools.
• Strong oral and written communication skills.
• Strong analytical and computer skills.

Nice-to-Have

• DVM and 2 years of experience.
• Management experience.
• Demonstrated skills in planning, scheduling, forecasting, including the use of relevant IT tools.
• Note: Hiring Manager to include tools, models and system examples based on the specific requirements.

ROLE SUMMARYThe Parenteral Center of Excellence (PCoE) Process Modeling Lead is a part of the PCoE Digital Team, responsible for providing digital design/development support, on a portfolio of projects ranging from early development to launch. The role will provide leadership in Chennai for other Process Modeling Scientists/Engineers, and cover all areas of modeling for product development chemistry, process engineering, mechanical design, data analysis (review, interpretation, visualization etc.)Responsibilities

• Design, plan and execute digital modeling projects to support the development of PCOE pipeline products
• Collaborate with cross functional teams within and outside PCOE to support the established Digital Strategy
• Partner across PSSM Digital Teams to optimize solutions and maximize value/delivery.
• Partner with the Digital and/or Manufacturing Intelligence team to build a strong technical expertise and skill base
• Lead partnerships with external service providers, Indian Institutes of Technology or other academic institutions to identify high impact solutions and resources to delivery PSSM Digital Strategy
• Stay abreast of industry trends and developments to ensure alignment with solutions and opportunities
• Identify new Digital tools, technology or areas of development to enhance PCOE Digital teams capabilities.
• Lead a team that that provides high quality support across a range of advanced modeling and analytics projects
• Collaborate effectively internally and with cross-functional teams and key stakeholders with an open attitude towards fast learning.
• Effectively manage complex project portfolios and priorities, with a strong focus on business return
• Communicate effectively at multiple levels covering project technical details or progress and impact updates to key stakeholders

BASIC QUALIFICATIONS

• Doctoral degree in chemical, mechanical, pharmaceutical engineering, physical sciences or related disciplines, with relevant educational background in computational modeling (experience with CFD, FEA or other numerical analysis, with an ability to work with a mainstream CFD software). Knows a 3D design software.
• Strong understanding of engineering fundamentals, including fluid mechanics, heat and mass transfer and solid mechanics.
• 10 years hands-on industrial experience (with relevant experience in Pharma, with Device development exposure) in providing solutions to complex technical problems applying scientific approaches.
• Familiarity with and understanding in leveraging modeling and simulations for process development and tech transfer needs. Demonstrated initiative in developing and implementing innovative solutions.
• Be comfortable being hands-on and taking a deep dive into novel technical areas when required, to achieve broader objectives. Is creative, innovative, and dynamic. Has an excellent synthetic and analytical mind and an aptitude for problem solving.
• 2 4 years experience in leading and directing teams
• Be a good listener, understanding the needs of non-engineer internal customers. Excellent oral communication, technical writing, and interpersonal skills (fluent in English).
• Good teaming skills and ability to work with wide range of technical teams and projects, internal and external partners.
• Working knowledge of data analytical approaches.
• Demonstrated Programming experience (Python, Matlab).

, Why Patients Need YouPfizer s purpose is to deliver breakthroughs that change patients lives. Research and Development is at the heart of fulfilling Pfizer s purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will applycutting edge design and process development capabilities to accelerate and bring the best-in-class medicines to patients around the world. What You Will AchieveWhen you join Pfizer,youll be joining a company and team with a desire to bring new, cutting-edge medicines to patients around the world. As a member of our team, youll use science and technology to design, characterize and develop the solid form of active pharmaceutical ingredients (API) and drug product formulations from discovery to commercial launch. You will be able to leverage your existing scientific knowledge, as well as develop in new areas, to evaluate the chemical & physical stability, bio-performance and manufacturability of the drug product across a diverse range of therapeutic areas.As a Senior Principal Scientist, you will be at the center of our operations andyou ll find that everything we do, every day, is in line with an unwavering commitment to quality. You will be recognized as an outstanding scientist in your group. With your advanced knowledge of the discipline, you will regularly contribute in multi-disciplinary teams representing the department and influencing cross-functional teams. Your innovation is seen in way you promote the use of novel experimental approaches, create processes, hypotheses and methodologies. You will be using your scientific judgment to adapt standard methods and techniques by applying prior work experience. You will be entrusted withidentifying and developing scientific strategies to support scientific goals and set the direction for business unit projects. You will undertake mentoring activities to guide team members.Through yourexpertise and extensive knowledge, you will be able to foster a culture that promotes innovation and thrives on doing better for patients and healthcare.How You Will Achieve It

• Apply technical and functional knowledge to design and independently execute experiments/projects, contributing to the overall direction of project.
• Act as a scientific resource within own sub-function/therapeutic area/discipline.
• Work with key stakeholders in Medicinal Sciences, Commercial, Clinical, Pfizer Global Supply (PGS) and other partner lines to define the product concept and lead the operational planning for projects.
• Provide clinical research pharmacy expertise in the development and management of investigational products at a program and protocol level (i.e. investigational product handling manuals/pharmacy manuals for utilization by clinical sites).
• Provide clinical pharmacy expertise in the development and management of investigational product handling manuals/pharmacy manuals for utilization by clinical sites.
• Educate clinical site personnel through in-services, investigator meetings and clinical site initiations or follow-up visits on the proper handling and use ofinvestigational products.
• Work closely with the Category Lead in the relevant therapeutic area to ensure the strategy being developed for each asset is communicated and represented clearly.
• Provide consultation to clinical project teams on medication/device related issues, such as concomitant medications, exclusionary medications and patient compliance/adherence issues.
• Lead multi-disciplinary initiative teams in the development and implementation of innovative products and processes tooptimizeinvestigational product use.
• Provide guidance to team members and customers regarding operatingunits and research functions.
• Mentor/lead/manage other research pharmacy team members.

QualificationsMust-Have

• Doctoral Degree (PhD/PharmD) and 8 years of experience.
• Demonstrated influencing and negotiatingskills and proven skills in developing others within their own functional area.
• Strong skills in planning, scheduling, forecasting, including the use of relevant IT tools.
• Strong oral and written communication skills.
• Strong analytical and computer skills.

Nice-to-Have

• DVM and 2 years of experience.
• Management experience.
• Demonstrated skills in planning, scheduling, forecasting, including the use of relevant IT tools.
• Note: Hiring Manager to include tools, models and system examples based on the specific requirements.

ROLE SUMMARYThe Parenteral Center of Excellence (PCoE) Process Modeling Lead is a part of the PCoE Digital Team, responsible for providing digital design/development support, on a portfolio of projects ranging from early development to launch. The role will provide leadership in Chennai for other Process Modeling Scientists/Engineers, and cover all areas of modeling for product development chemistry, process engineering, mechanical design, data analysis (review, interpretation, visualization etc.)Responsibilities

• Design, plan and execute digital modeling projects to support the development of PCOE pipeline products
• Collaborate with cross functional teams within and outside PCOE to support the established Digital Strategy
• Partner across PSSM Digital Teams to optimize solutions and maximize value/delivery.
• Partner with the Digital and/or Manufacturing Intelligence team to build a strong technical expertise and skill base
• Lead partnerships with external service providers, Indian Institutes of Technology or other academic institutions to identify high impact solutions and resources to delivery PSSM Digital Strategy
• Stay abreast of industry trends and developments to ensure alignment with solutions and opportunities
• Identify new Digital tools, technology or areas of development to enhance PCOE Digital teams capabilities.
• Lead a team that that provides high quality support across a range of advanced modeling and analytics projects
• Collaborate effectively internally and with cross-functional teams and key stakeholders with an open attitude towards fast learning.
• Effectively manage complex project portfolios and priorities, with a strong focus on business return
• Communicate effectively at multiple levels covering project technical details or progress and impact updates to key stakeholders

BASIC QUALIFICATIONS

• Doctoral degree in chemical, mechanical, pharmaceutical engineering, physical sciences or related disciplines, with relevant educational background in computational modeling (experience with CFD, FEA or other numerical analysis, with an ability to work with a mainstream CFD software). Knows a 3D design software.
• Strong understanding of engineering fundamentals, including fluid mechanics, heat and mass transfer and solid mechanics.
• 10 years hands-on industrial experience (with relevant experience in Pharma, with Device development exposure) in providing solutions to complex technical problems applying scientific approaches.
• Familiarity with and understanding in leveraging modeling and simulations for process development and tech transfer needs. Demonstrated initiative in developing and implementing innovative solutions.
• Be comfortable being hands-on and taking a deep dive into novel technical areas when required, to achieve broader objectives. Is creative, innovative, and dynamic. Has an excellent synthetic and analytical mind and an aptitude for problem solving.
• 2 4 years experience in leading and directing teams
• Be a good listener, understanding the needs of non-engineer internal customers. Excellent oral communication, technical writing, and interpersonal skills (fluent in English).
• Good teaming skills and ability to work with wide range of technical teams and projects, internal and external partners.
• Working knowledge of data analytical approaches.
• Demonstrated Programming experience (Python, Matlab).

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Keyskills :
apichemical analysisdmffilingcenter of excellenceresearchdevelopmentequal employment opportunitycontinuous improvement facilitationtech transfermass transferproject plansproject teamschange controlfda