Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and the potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.
Join Us for Regular Vacancy Updates on –
At Pfizer we know that great things happen anywhere people come together with one shared goal. And the greatest rewards are sometimes where you least expect them. The future of medicine is happening at Pfizer
Position: Sr Executive – Analytical R&D
Location: Chennai, Tamil Nadu, India
- The purpose of this function is to perform Analytical R&D activities such as method development, method validation, method transfer, in-process/complete analysis, and stability study.
- He / She shall perform other essential duties as and when required/assigned.
- To adhere to both quality and safety compliance according to organizational policies/procedures and regulatory guidance.
- This position will also hold the responsibility to identify and champion the implementation and harmonization of technical programs/projects related to improving and/or contemporizing new technologies applicable to analytical methods.
- Perform assessments of existing data packages, feasibilities, and conclude remediation.
- Carry out spectroscopic characterization and verification process of the materials through consistent and effective use of Pfizer SOPs/Tools.
- Ensure technical output is compliant with all Global Training Curricula for the instrument operations, material handling, and certifications related to, Quality Ops, Manufacturing, and EHS.
- Collaborate with QTS MIR/LIR user council representatives to identify opportunities for system improvement.
- Communicate planned changes if any related to QTS users.
- Work with the Quality Assurance and other cross-functional teams to facilitate the consistent, disciplined execution of the LIR/ER/CAPA quality system ensuring the completeness and comprehensiveness of the assigned task.
- Review and analyze corrective and preventive actions’ effectiveness through appropriate tracking and trending methods in order to prevent the reoccurrence of issues.
- Engage in method robustness program by contributing in gap assessment, remediation, and analytical method validations.
- Ensures compliance with local and corporate procedures and ensures all data packages are audit ready and transferable.
- Perform the peer review of draft data packages submitted by other analytical team members.
- Ensure appropriate GT&E LT review of the formal reports that are considered milestones for decision making.
- Coordinate with cross-functional teams to ensure timely execution and resolution of all deliverables versus target milestones.
Desired Skills & Competencies:
- Minimum Masters or Ph.D. in pharma, engineering, or science discipline
- Demonstrated technical capabilities with a successful track record of development, remediation, validation, and transfer of analytical methods.
- Education and technical areas of expertise should include the majority of fields of analytical technologies, compendia, regulatory guidance, and current scientific developments.
- Experience in analytical equipment and process qualifications and validation activities.
- Strong decision making, critical thinking skills, and the ability to work systematically through complex issues. Capability to make informed assessments of risk and independently develop risk mitigation strategies.
- Proficient with the use of a variety of problem-solving (DMAIC), risk analysis, and statistical tools. Advanced OPex skills desirable, preferably with Pfizer Green/Black belt level certification.
- Possess excellent communication skills and the ability to articulate complex issues clearly and concisely. Understands the importance of effective stakeholder management and communications.
- Strong scientific skills and proven track record of being able to “lead from the front” and deliver timely solutions to complex problems.
- Action bias and collaborative by nature. Demonstrated track record of being able to work effectively across cross-functional boundaries.
- Capability to make informed assessments of risk and independently develop risk mitigation strategies.
- Ability to engage with colleagues and develop effective relationships across SM/GTE teams and stakeholders at all levels.
- Decisive and action-oriented leader, with strong problem-solving and analytical skills.
- The recognized scientists with the capability to influence both internally and externally.
- Capable of independently developing and managing technical project plans, timelines, and deliverables across cross-functional teams.
- Strong working knowledge of the Quality/GMP/ICH/compliance systems of the Drug substance/Sterile Injectable pharmaceutical industry and regulatory body’s requirements.
- Possesses Tech writing competencies at level NLT 75% BEC score.
- Possess in-depth technical expertise on products and technologies associated with the manufacturing or labs, and a thorough understanding of product and process and how manufacturing operations can influence product characteristics
- Strong understanding of cGMP requirements, validation (process and/or analytical), and contemporary regulatory requirements and guidelines.
- Demonstrated ability to plan, implement, and achieve complex goals and objectives.
- Ability to manage complex technical details coupled with the ability to remain focused on the business needs
- Strategically analyses the risks, benefits, and opportunities of various solutions and anticipates and considers the scope of impact a decision will have on other groups and the business unit
- Often participates in projects that are more complex and may have considerable technical risk and assign priorities to multiple competing and important activities quickly and effectively.
- Takes timely strategic actions in designing and leading groups to facilitate them working together effectively
- Anticipates the impact of industry trends and develops strategic plans in the best interest of the business
- Uses judgment, knowledge, and experience to define a project course of action, resources requirements, and priorities
- Team player by preference with the proven ability to work independently across organizational boundaries.
- Demonstrated ability to influence and negotiate across teams, sites, and organizational networks. Ability to lead and influence at all levels of the organization.
- Strong team player with a proven track record of managing and building relationships both within and across cross-functional teams.
- Completer/finisher by nature with a strong history of delivery across multiple complex programs.
- Self-starter, highly motivated individual, with an action bias and collaborative by nature. Demonstrated track record of being able to work effectively across cross-functional boundaries.
- Plays a major role in internal teams and in influencing external groups
Experience: 7-12 Years
Join Us for Regular Vacancy Updates on –