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Sr. Scientist, Formulation Development-Bedford Ohio
4 months ago
Senior Scientist, Formulation Development - Injectables
Overview
Senior Scientist, Formulation Development is responsible for the formulation and process development activities associated with drug product development projects following Quality by Design (QbD). Participates in the design of the control strategy for the manufacturing process. Shares responsibility for technical decision making for formulation and process related issues on the team. Position involves executing assigned tasks within the constraints of the published timelines. Responsible for the design and execution of non-routine, complex processing or compounding studies (up to 40% of their total workload) and training of laboratory personnel in areas of expertise.
Responsibilities
* Development and execution of product development strategies that are aligned to relevant regulatory processes, Quality by Design requirements and guidelines;
* Formulation and process design and development, as well as associated technical decision making;
* Develops and executes robust experimental designs (e.g. using factorial design of experiments) studies to the highest scientific standards to achieve the center's goals. Including working knowledge of statistical data interpretation tools;
* Seeking and incorporating feedback/requirements from the Technical Services and Operations teams into formulation and process development. Supporting development from early stage through FDA submission;
* Collaboratively working with R&D colleagues, Technical Services, Regulatory Affairs to ensure all submission documents are prepared to the highest quality and to pre-determined timelines;
* Keeps abreast of relevant literature and developing visibility outside of functional area. Continues to improve the center's technical knowledge and product development processes;
* Responsible, in collaboration with management, to develop and track project timelines and assumes departmental responsibility for projects when necessary. May deliver updates to senior level management in context of overall project goals;
* Assumes additional responsibility for departmental staff as needed including recruiting, managing, and developing scientific staff;
* Contributes to departmental administration. Demonstrates fiscal responsibility with respect to lab equipment need and capital cost projections, cost of experiments, technology, external collaborations, and travel;
* Responsible for technical reporting and quality in a timely manner where thoroughness and correctness are critical to successful transfer of products to operations sites;
* Maintain publication/presentation/patent record as appropriate for discipline;
* Has ability to participate as representative on multiple project teams and contribute to defining expertise-related aspects of overall program goals. Acts as the department representative and communicates the line recommendations to the project team and reports back the project team decisions to the line management;
* Develops broad knowledge in field of expertise, including the ability to interpret current literature relevant to R&D projects, and visibility outside of functional area. Provide guidance and expertise to advance specific projects or evaluate and propose new technologies and concepts in support of multiple projects;
* May be involved in or may lead in product lifecycle activities including analytical and process optimization, actions associated with product monograph updates, actions associated with regulatory guidance updates and actions associated with corporate site renovation, new construction or acquisitions.
Skills
* Demonstrates a broad and in-depth knowledge of different types/platforms of parenteral formulations, materials characterization, process development, and scale up of sterile injectable products. Experience in controlled release parenterals is a plus;
* Expertise in processing and scale-up aspects (e.g. lyophilization, filter validation and mixing technologies) is required;
* Knowledge of analytical science as it relates to pharmaceutical product development is required - including HPLC, GC, LC/MS, and other spectroscopic techniques;
* Thorough knowledge of FDA regulatory guidances, ICH guidelines and requirements of ANDA submissions;
* Advanced training in the area of technical expertise and demonstrated knowledge of field;
* Computer literacy required including e-mail and fundamental computer navigation. Proficiency in the use of Microsoft Office products including Word, Excel as well as project planning techniques and software;
* Strong systematic and methodological approach(es) to problem solving and troubleshooting.
* Good communication skills, both oral and written in an inter-disciplinary environment with clear awareness of efficient meeting and teleconferencing etiquette;
* Close concentration and uniform mental attention;
* Demonstrates strong leadership and influencing skills;
* Demonstrates ownership, initiative as well as the ability to deal with and resolve ambiguity;
* Self-motivated with ability to work under pressure to meet deadlines.
Qualifications - Education and Experience
Minimum: BSc/MSc in Pharmaceutical Sciences, Biomedical Engineering, or Chemical Engineering + 15 years relevant experience
Preferred: PhD in Pharmaceutical Sciences, Biomedical Engineering, or Chemical Engineering + 10 years relevant experience
What We Offer
* Clean climate-controlled working environment
* Annual performance bonus potential
* 401k employer match up to 6% of your contributions
* 23 vacation/personal days
* 11 paid Company holidays
* Generous healthcare benefits
* Employee discount program
* Wellbeing rewards programs
* Safety and Quality is a top organizational priority
* Career advancement/growth opportunities
* Tuition Reimbursement
* Maternity and Parental Leave
* Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to a specific plan or program terms.
Location:
Bedford, OH, US, 44146
Nearest Major Market: Cleveland
