Sunovion Senior Scientist, Analytical Services in Marlborough, Massachusetts
Sunovion Pharmaceuticals is looking for a Senior Scientist to join our Analytical Services team in Marlborough, MA.
The Senior Scientist, Analytical Services, Technical Operations & Quality (TOQ) is responsible for development of analytical methodologies, oversight of analytical testing at contract laboratories and contract manufacturing facilities for method validation, method transfer and testing on development and commercial pharmaceutical products and Active Pharmaceutical Ingredients (API). Interacts with internal multidisciplinary teams to ensure successful delivery schedules of analytical test reports or certificates. Assists with QC checks and preparation of regulatory filings (INDs and NDAs). Support projects associated with drug substance and drug products by delivering data science solutions by mining large-scale data, developing predictive modeling, and designing data interpretations through visualization tools for effective decision-making. The incumbent will interface across TOQ as well as other functions (R&D, Regulatory and SP-TRDD). This individual will be expected to proactively look for ways to optimize data management, analysis and provide insights to our internal and external partners.
Analytical method development (HPLC, GC, Dissolution) for raw materials, intermediates, drug substances (APIs) and drug products, and qualification/validation of such methods.
Manage drug substance and drug product (commercial and clinical trial materials) analytical testing at contract laboratories. Manage contract lab activities to ensure compliance and timeliness of C of As and reports. Investigate and resolve test failures.
Manage stability programs including evaluation of stability requirements, planning and coordinating stability studies, creating and maintaining stability study plans, performing data analysis, authoring stability reports, and maintaining master stability protocols
Develop and maintain statistical models to support TOQ such as statistical process control, multivariate analysis, and process analytics. Conceptualize and deploy data science solutions in support of continuous improvement.
Approve and issue drug substance, component, and/or drug product and packaged clinical trial material C of As.
Collaborate on investigations, and operational excellence initiatives (manufacturing CPV data trending), and process change assessments through data mining, statistical analysis, and visualization. Conduct trend analysis of data including writing Annual Product Review sections.
Represent analytical services function in cross-functional teams for Sunovion products and projects including providing analytical support for manufacturing investigations.
Responsible for preparation of Regulatory filings (INDs, NDAs, Supplements, DSUR, and Annual Reports) including the writing of CMC sections.
Communicate and visualize the output of analyses, including both written and verbal communication, to business leaders and non-technical audiences.
Lead by demonstrating exceptional collaboration. Influence across the matrix without direct authority.
Other duties as assigned.
Minimum Education, Experience, Knowledge and Skills Required:
Bachelors or advanced degree in life sciences or engineering with 2-5 years of experience.
Any experience in an FDA-regulated biotechnology, pharmaceutical or medical device company with direct exposure to laboratory operations, documentation practices, and quality systems is a plus.
Knowledge of probability distributions, sampling methods, and other statistical concept along with the use of software packages such as JMP, MATLAB, Minitab, etc. and visualization tools (Tableau, Power BI, Spotfire, etc.).
Knowledge of Microsoft tools (Excel, SharePoint, etc.).
Ability to define and propose meaningful data-driven solutions, complete deliverables, and translate business questions to analytically justified actions/solutions to non-technical colleagues.
Excellent conceptual & analytical thinking, the drive to seek information, and have the confidence & initiative to implement the solution with high attention to details.
Self-directed, accomplishment-driven individual with a strong sense of passion and urgency who can work both independently and in a cross-functional team environment.
Strong verbal and written communication and interpersonal skills, with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization.
Ability to build strong relationships, participate and influence across large, complex organizations to drive alignment and change where the resources and decisions are outside of the leaders direct reporting line.
Ability to manage multiple tasks and deadlines with attention to detail.
Willingness to grow within group and company (e.g., taking on higher levels of responsibility, rapport building with other groups), to learn new skills and to teach these skills to others when required.
Health and Safety: To maintain the health and safety of our employees, patients, and affiliates, as well as comply with the vaccination requirements of our partners, employees are required to be vaccinated against COVID -19. Candidates hired must provide proof of vaccination against COVID-19 within 5 days post hire as a condition of employment. In accordance with Equal Employment Opportunity laws, exemptions for religious and medical reasons will be considered.
Confidential Data : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
Compliance :Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sunovion are carried out with the "best" industry practices and the highest ethical standards.
Mental/Physical Requirements : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
Sunovion Pharmaceuticals Inc. is an Equal Employment Opportunity (EEO) and Affirmative Action employer
Sunovion is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
For more information about EEO and the Law, please visit the following pages:
Equal Employment Opportunity is THE LAW (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf)
EEO is the Law Poster Supplement
Pay Transparency (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
Lead the way to a healthier world by putting patients at the center of everything we do
We are focused on developing innovative therapies and transforming the lives of people with serious medical conditions. We are creating innovative psychiatric, neurological and respiratory therapies that help transform people's lives, while at the same time we are playing an increasingly active role in the future of global health.
Sunovion Pharmaceuticals Inc. is an Equal Employment Opportunity (EEO) and Affirmative Action employer. Sunovion is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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