Senior Manager, Specialized Chemical Development
Senior Manager, Specialized Chemical Development
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Salary Not Disclosed
1 Vacancy
Job Description
The Role:
The Sr. Manager Specialized Chemical Development will support assigned process chemistry activities for drug substance (DS) DS intermediates and starting materials. The initial main focus for this position will be an oligonucleotide project though work on small molecule or other modalities will be future possibilities. The scope of the role encompasses process research scale-up activities process definition Process Performance Qualification (PPQ) and characterization/design-space mapping; it may include Person in Plant (PIP) oversight of manufacturing processes. Collaboration with Process Engineering will occur during routine manufacturing technical transfer PPQ and process improvement initiatives. Operating within a virtual (100% outsourced) business model the employee will participate in CDMO selection and oversight in conjunction with internal teams and will be expected to foster the development of strong and enduring business partnerships. Strong technical writing skills are required as this position will be involved in the development review and approval of Module 3 sections of CTD regulatory submissions written responses to regulatory authorities and other critical technical documents.
This position will be located at the Waltham Massachusetts office though remote candidates will also be considered. Occasional domestic and international travel (up to 25%) will be required.
What Youll Do:
- Support/manage process development activities and API scale up for an oligonucleotide project and other Deciphera assets. Critically analyze process and analytical data to identify and resolve key challenges during development.
- Participate in process chemistry teams or subteams engaged in external cGMP manufacturing of drug substance DS intermediates and starting materials. Evaluate and implement innovative and practical synthetic routes to starting materials intermediates and drug substances.
- Work closely with internal Quality Assurance Regulatory CMC Supply Chain Process Engineering external manufacturing operations and other external and internal partners to ensure operational excellence with respect to timelines and attainment of technical regulatory and quality objectives.
- Participate in the selection of drug substance CDMOs based upon core capabilities capacity and track record of regulatory compliance; participate in the evaluation of site technical quality and business performance.
- Develop and maintain strong relationships with CDMO business partners.
- Review and author technical reports controlled GMP documents (including master and executed batch records) and CMC content for Module 3 sections of regulatory dossiers.
- Continuously monitor vendor relationships; identify risks and establish mitigation plans and/or best practices to proactively address supply chain risks.
- May represent the Technical Operations organization in meetings with FDA EMA and related regulatory authorities.
- May provide Person-in-plant coverage during critical manufacturing events at CDMOs.
Qualifications :
- PhD or equivalent plus 3 years of experience or Bachelors/Masters plus 8 years of experience in pharmaceutical synthetic process research development and commercialization. Previous oligonucleotide experience strongly preferred.
- Familiarity with analytical techniques and manufacturing operations particular to oligonucleotides and other larger molecules (including preparative chromatography) is desirable.
- Track record of success in participating on teams for drug substance programs in a 100% outsourced environment.
- Experience with vendor/supplier management and excellent communication and cross-functional collaboration skills.
- Competency in developing implementing and delivering project plans (milestones timelines resources etc.) to successful endpoints.
- Ability to communicate effectively both in oral and written form including preparation of internal reports and external communication with Deciphera partners.
- Strong decision-making skills and ability to influence internal and external stakeholders.
- Knowledge of the drug development process and ICH requirements for NDA and MAA registration. Experience in working with regulatory authorities. Experience authoring Module 3 CTD content.
- Ability to travel (up to 25%) to CDMO domestic and international sites.
- Fluency with standard computer software packages (MS Word Excel and PowerPoint SciFinder ChemDraw) and JMP (or similar statistical tools).
Additional Information :
Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $139000.00 - $191000.00. Actual compensation packages will depend on various factors including but not limited to depth of experience education skillset overall performance and/or location.
Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Decipheras competitive total rewards strategy that also includes annual performance bonus a long-term incentive plan full range of benefits and other incentive compensation plans (if applicable).
Benefits:
- Competitive salary and annual bonus.
- Comprehensive benefits package including medical dental vision insurance 401(k) retirement plan with company match and more.
- Generous parental leave and family planning benefits.
- Outstanding culture and opportunities for personal and professional growth.
Apply Now: Join us in our mission to improve the lives of people with cancer. Apply today to become a part of our dynamic team!
EQUAL EMPLOYMENT OPPORTUNITY INFORMATION
Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
