Sr Research Scientist I - Biologics Drug Product & Device Development

Profile

Specific Responsibilities
**MEMBERS ONLY**SIGN UP NOW***. Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining **MEMBERS ONLY**SIGN UP NOW***., you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases. **MEMBERS ONLY**SIGN UP NOW***. has an opportunity for an experienced candidate in Drug Product and Device Development for our Biologics Development operations at our Oceanside facility in Southern California. This position will report into the group leadership focusing on the development of devices and drug-device combination products, particularly auto-injectors and pre-filled syringe systems. We are seeking a motivated, team oriented individual with expertise and thorough understanding of drug-device development as well as significant experience with Regulatory Filings including authoring BLA/MAA. Specific Responsibilities and Skills for Position:
• The successful candidate will have demonstrated expertise in developing biologics combination products (auto-injectors, pre-filled syringes, etc.) through late-stage clinical development and licensure. Experience with novel delivery devices is desired.
• The successful candidate will have direct experience and expertise in Device Design Control, Human factors engineering, combination product design verification and validation, and creation and maintenance of Design History Files.
• The selected candidate will lead device evaluation, design and optimization as related to combination drug products. Establish and oversee testing conducted at contract sites as well as procure in-house equipment as needed to manage project-related development activities.
• The successful candidate will be expected to provide technical leadership in selecting device suppliers including setting/negotiating specifications, AQLs, supply chain consideration and participating in quality investigations as needed.
• Thorough understanding of the relationships between formulation, process, and device design as related to drug-device performance, quality and stability.
• Author/review global Regulatory submissions. A thorough knowledge of current US, and global Regulations, ICH guidance, ISO standards, and quality system regulations for combination products is essential.
• Lead technology transfer of combination product manufacturing processes to clinical and commercial manufacturing sites and assist in quality investigations. Experience working with Drug Product/Device CMOs is desired.
• The applicant must be an effective communicator of ideas, project goals and results to team members across cross-functional roles/departments and provide guidance and project leadership based on organizational goals.
• Candidates should be self-motivated and organized, familiar with the relevant literature, and enjoy scientific investigation and thinking, proactively identify issues and develop solutions in a collaborative multidisciplinary environment. The applicant is also expected to exercise considerable latitude in determining objectives and approaches to assignments.
• The successful candidate for will ensure that device and drug-device combination product development is proactively managed and meets the company’s timelines for program development. The successful candidate will work together with line management to identify the resource requirements and technical challenges that must be overcome to accomplish the team’s goals. The successful candidate will educate staff and ensure that the Biologics Formulation team functions at a high level to meet all program objectives.
Essential Duties and Job Functions
• Responsible for developing biologics combination products, particularly, auto-injectors, pre-filled syringes, through late-stage clinical development and licensure.
• Responsible for developing processes for the manufacturing of biologics combination drug products.
• May lead projects in late-stage clinical trials.
• Must have a thorough understanding of the GMP environment, GMP compliance, novel route generation and implementation.
• Investigates the feasibility of applying advanced principles and techniques of related scientific specialty to products and problems.
• Provides direction to members of project teams in the initiation and execution of laboratory experimentation, considering economic, regulatory and safety factors.
• Works on complex problems where analysis of situations or data requires evaluation of intangible variables, requiring regular use of ingenuity and creativity.
• Makes contributions to scientific literature and conferences through presentation of research results.
• Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
• Demonstrates ability to recognize anomalous and inconsistent results and interpret experimental outcomes.
• Maintains in-depth knowledge of principles and theories, applying such knowledge to the research direction that supports Company interests.
• Demonstrates technical proficiency, scientific creativity, collaboration with others and independent thought in suggesting experimental design and research strategy.
• Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.
• Demonstrates collaborative communication and problem solving spirit.
Knowledge, Experience and Skills
PhD 7 years relevant industry experience, BS/MS extensive industry experience in related scientific field or engineering discipline. Work experience must demonstrate an expertise in device and combination product development and sustained excellence in performance and accomplishments that align to company goals. Excellent communication skills (both verbal and technical) and interpersonal skills are required. Exercises independent judgment in developing methodologies, techniques and evaluation criteria for obtaining results. Demonstrates ability to recognize anomalous and inconsistent results and interpret experimental outcomes. Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills. As an equal opportunity employer, **MEMBERS ONLY**SIGN UP NOW***. Sciences Inc. is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact **** for assistance. For more information about equal employment opportunity protections, please view the EEO is the Law poster. #LI-MM1
As an equal opportunity employer, **MEMBERS ONLY**SIGN UP NOW***. Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without regard to race, color, religion, national origin, gender, age, sexual orientation, disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ****
for assistance.
For more information about equal employment opportunity protections, please view the ‘EEO is the Law’
poster.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
**MEMBERS ONLY**SIGN UP NOW***. provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

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