Assistant Cmc Technical Writer Jobs in Arkansas

Develop and manage budgets for CMC operations, ensuring cost-effectiveness while maintaining high-quality standards

Forecast and manage the supply of drug product for clinical trials

A minimum of 10-12 years experience in pharmaceutical or biotechnology CMC development with regulatory interactions experience

Excellent cross-functional leadership, team building, and communication skills

Proven experience in tech transfer, manufacturing scale-up, and validation of biotechnology products

Hiring Manager Interview (45 minutes)

BS in a quantitative or scientific discipline with 4+ years of relevant data science/analytics experience in the pharmaceutical industry

Experienced with computer languages (R, Python, SQL, etc.) and statistical software packages (JMP, Statistica, Minitab, etc.) to manipulate and analyze data

Experienced with business informatics tools (e.g. Tableau, Power BI, Spotfire)

Prior experience working in a GMP environment and understanding of bioprocessing unit operations is a must

Drive and support data pipeline initiatives

Engage with the delivery of new process analytics tools cross-functionally

Ensure teams active, aligned communication in functional and cross-functional management reviews and governance meetings

Job Title: CMC Project Manager - Remote

Establish and manage collaboration and team sites. Track delivery and create repositories for all PD deliverables

Assist PD in driving decision making and communication

Pay Rate: $70/hr to $75/hr

Excellent oral and written communication skills for effectively interfacing with higher levels of management and departments within the company

Support BLA/MAA/ROW (emerging markets) expansion effort for a biologics project, including compilation of market-specific requirements and leading information request response preparation.

Ad hoc RA CMC support to line manager.

Good writing skills for technical writing

***Compensation is based on experience***

Track submission activities and change controls for RACMC and ensure visibility to cross-functional CMC stakeholders.

Strong project management skills, with the ability to manage multiple projects simultaneously.

Develop and implement CMC regulatory strategies for new product development and product lifecycle management.

Knowledge of regulatory requirements and guidelines, including FDA and EMA regulations

Manage and oversee the preparation and submission of regulatory documents, including INDs, BLAs, and amendments.

Provide guidance and support to cross-functional teams on regulatory CMC requirements and strategies.

Stay up to date with changes in regulatory requirements and industry trends that may impact product development and regulatory submissions.

Good knowledge in CMC strategy, risk and resource management, regulatory requirements and ICH guidelines;

Strategic view and leadership abilities as well as hands-on problem solving skills. Experience in managing projects is required;

Get buy-in and sponsorship from Management to ensure project success;

Knowledge of FDA, EU, WHO, NMPA and PIC/S GMP requirements;

Extensive working experience and knowledge in vaccines analytical and process development, business development, manufacturing and scale-up, quality and regulatory;

Act as technical leader in client interaction and internal function discussion during proposal preparation to enhance current service offerings;