Associate Director. Technical Project Management

Digital Chemistry, Manufacturing, and Controls (dCMC) Business Owner

Digital Chemistry, Manufacturing, and Controls (dCMC) is a cross-divisional initiative that will enable the pipeline by establishing a digital continuum of data from development through manufacturing for our products and processes. dCMC intends to deliver :

• Increased productivity and speed to clinic / market
• Accelerated timelines for site, filing, and launch readiness
• Improved access to product and process data
• Streamlined transfer of process and product knowledge with reduced error rates

Digital CMC will implement digital solutions to install the foundational capabilities needed to realize the vision of frictionless flow of data from development to commercialization and supply. A key workstream within this initiative is the auto-generation of regulatory filing sections, enabled by a dedicated application designed to create a frictionless flow of data from source systems to regulatory documentation.

Under the guidance of dCMC Regulatory Authoring Leadership, the Associate Principal Scientist, Regulatory Authoring Business Owner, will optimize regulatory authoring processes and enhance data management by working with the business areas to define the optimal route to digitize the authoring of regulatory filing sections. The applicant will work closely with the cross-functional team to develop and implement the digital solution, prioritizing those features that provide the most value to the business area scientists across initial market applications, clinical submissions, and post approval supplements.

In addition, the applicant will work with the extended team to develop data governance principles to ensure scalability and continued success of the developed solution.

Responsibilities

The responsibilities of the dCMC Business Owner include :

Required Skills and Experience

Knowledge of manufacturing, testing, quality, and supply chain processes from late clinical development through commercialization, with practical insight into how these operations generate CMC regulatory content

Understanding of CMC operations, technology transfer, control strategy development, and regulatory authoring requirements that inform automated filing generation

Hands-on experience in regulatory authoring and submission documentation, including preparing, reviewing or supporting filing ready content and structured filing outputs

Proven ability to deliver results in a complex environment with shifting priorities and multiple stakeholders

Experience in digitization and data management initiatives in regulated environments, including creation of re-usable data products, data modeling, and data governance

Working knowledge of key enterprise systems (LIMS, MES, SAP) and practical experience coordinating their integration into data pipelines, APIs or ETL processes for downstream authoring use

Skilled in creating and managing detailed cross-functional project plans and driving execution with accountability

Strong team contributor, promoting an inclusive and collaborative environment

Effective problem-solving, conflict resolution, and ownership-driving skills

Excellent verbal and written communication, with the ability to tailor messages to the audience and actively listen

Highly organized, able to prioritize tasks to ensure project success

Demonstrated project management skills, including leading cross-functional workshops, gathering and prioritizing requirements, and defining and tracking KPIs

Preferred Experience and Skills

Experience implementing or supporting automated regulatory authoring (structured content, template-driven generation, or document assembly) from source systems

Background in analytical development or commercialization, with knowledge of method development, validation, specification setting and justification

Practical knowledge of content models / structured content, metadata, and data template design to enable automated authoring

Experience with data integration patterns and tools (APIs, data pipelines) and relevant systems (LIMS, MES, SAP)

Experience in data governance, data stewardship, and data quality management in regulated environments

Education Minimum Requirement

B.S. in chemistry, engineering, or related field with a minimum of 8 years of experience in the pharmaceutical industry

M.S. in chemistry, engineering, or related field with a minimum of 6 years of experience in the pharmaceutical industry

Ph.D. in chemistry, engineering, or related field with a minimum of 3 years of experience in the pharmaceutical industry

Required Skills

Accountability, Communication, Data Governance, Data Modeling, Digital Transformation, Drug Development, Key Performance Indicators (KPI), Measurement Analysis, Medicinal Chemistry, Operating Models, Operational Excellence, Portfolio, Programme, and Project Support, Program Management, Project Management, Project Planning, Regulatory Documents, Risk Management, Roadmapping, SAP Master Data Governance (MDG), Stakeholder Relationship Management, Team Leadership, Technical Management, Technical Projects, Technology Transfer, Waterfall Model

Preferred Skills

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only : Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.

As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit : EEOC Know Your Rights

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds.

The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment.

We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.

This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

The salary range for this role is $139,600.00 - $219,700.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.