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Senior Lead Technology Scientist I/Senior Lead Process Engineer


Andover, MA
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Job Details

Position Summary

The Senior Lead Technology Scientist I/Senior Lead Process Engineer I will provide oversight for the manufacturing process monitoring program that is deployed in the three drug substance manufacturing suites. This position will work closely with colleagues to sustain a compliant process monitoring program while continuing to develop and implement more effective and efficient ways to proactively monitoring our manufacturing processes by leveraging new data, tools, statistical analyses and documentation practices. In this role, the individual will have active participation with relevant Pfizer and industry forums in order to ensure alignment with current regulations as well as influence the evolution of process monitoring in the industry. This position would also lead additional cross functional projects that would enhance our overall manufacturing process understanding hence enabling a successful process monitoring program.


In addition to the overall program management, this position is also responsible for assisting with sustainable support of the process monitoring program which includes performing and facilitating root cause analyses for process monitoring flags following the Six Sigma methodology. This individual will work closely with manufacturing and quality control analytical colleagues to observe and understand operations and methods to determine the potential sources of variability. This position offers an excellent opportunity to increase ones understanding of biotechnology drug substance manufacturing processes and quality control analytical methods. This individual will be trained in the six sigma methodologies and is expected to obtain a Six Sigma Certifications. Documentation of all work in a GMP compliant manner will be required.

Program and project management responsibilities include:

+ Sustaining and optimizing existing program

+ Lead team to develop optimizations/enhancements, determining the implementation approach and driving implementation

+ Effective stakeholder management which includes working closely with operations, quality control and quality assurance stakeholders to ensure alignment and support for the program and enhancements

+ Determining next steps, working offline to progress milestones, tracking and reporting progress to stakeholders and management

+ Provide guidance and mentoring to colleagues as needed

+ Process monitoring sustainability support includes:

+ Regular review of applicable data and control charts to understand how process is performing and looking for incomplete data

+ Facilitate weekly cross functional process monitoring meetings, tracking flag progression and resolution

+ Perform initial assessment of flags prior to process monitoring weekly meetings by facilitating communications with manufacturing operators and quality control analysts.

+ Observe and understand manufacturing unit operations and quality control analytical methods as needed

+ Perform root cause analysis of process monitoring flags using the Six Sigma methodology. This activity may be performed independently or as part a small team of subject matter experts. Some flag evaluations may be complex which become Six Sigma projects. This provides an opportunity to complete a Six Sigma Certification.

+ Build maintenance of univariate and multivariate monitoring models as needed

+ Responsible for communicating outcome for process monitoring program to the appropriate stakeholders


BS in Engineering, Science or related discipline and 8+ years' experience

Technical Skill Requirements:

Solid project management skills

Ability to lead teams and mentor colleagues

Solid understanding of Biotech Drug Substance Manufacturing processes

Solid knowledge of GMPs

Solid statistical data analysis skills

Excellent problem solving skills with experience with root cause analyses using Six Sigma (DMAIC) methodology

Excellent attention to detail, communication skills, including both verbal and written.

Solid computer skills including data extracting, querying, cleaning, manipulating (e.g., stack, split, join) and analyzing data

Proficient with databases and building and maintaining queries in SQL is a plus

Work Environment:

Majority of work in office environment. Gowning to enter a GMP clean room and standing will be required periodically to observe manufacturing operations. Standing will be required periodically to analytical method operations.

**EEO & Employment Eligibility**

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

**Last Date to Apply for Job:** 12/20/17

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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