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Product Safety Manager

Swiss American CDMO

This is a Full-time position in Garland, TX posted March 9, 2022.

Swiss American CDMO LLC is a topical drug and medical device manufacturing company founded to provide cutting-edge topical skincare technologies to selected markets.

Our business strategy consists of the development, manufacturing, and superior customer service to contract manufacturing customers worldwide.

A strong team approach to serve our customers is the basis of our mantra – “Partnering to deliver service through quality, integrity, and commitment.” Are you passionate about Service Excellence, Results, Integrity, and Leadership?

These are the core attributes we are looking for at Swiss-American CDMO, LLC.

Product Safety Manager

The Product Safety Manager will be a key strategic role to bringing new products (personal care products, OTC drugs, and medical devices) to the marketplace.

As a support to the corporate strategy, the Manager, Product Safety will be responsible for the creation and implementation of product and ingredient evaluation controls and documentation for the production of new products.

The position oversees, develops, plans, and generates Clinical, in vitro, in silico studies, and/or technical reviews which will insure the efficacy and safety of Swiss-American products or Swiss-American contracted formulations.

Position leads productive partnerships on conducting various studies and safety reviews on an internal basis across all Swiss-American business departments.

Collaborates the review of claims methodology and data to meet various Local and, or Global, needs through establishment of supportive evidence.

The position requires strong leadership capabilities and a level of experience in the fields of clinical development/operations, toxicology, regulatory and consumer efficacy/safety methodologies.

Position insures that Swiss-American product support evidence is among the most progressive and reliable in the industry.

The ideal candidate will have a self-directed work style and not be timid in seeking out information from outside sources and peers.

At the same time, this Is a highly collaborative work team and therefore, the individual must be able to work effectively as part of a team, sharing Information and supporting others in their roles, as needed.

Essential Duties and Responsibilities include the following.

Other duties may be assigned.

• Independently conduct robust safety assessments that meet global regulations on raw materials and finished formulations for different categories of products (e.

g.

skin care/personal care, medical devices, OTC drug, etc.).

• Identifies and leads technical opportunities to fulfill expected regulatory and safety needs via established and/or new test methods and technology.

Guide and select the development of test methods or “claims” and evaluations in conjunction with other departments, specific CROs, suppliers or testing facilities.

Sponsors and conducts appropriate evaluations to substantiate the value of novel technology and disseminates information to make the technology accessible to coworkers for product development objectives.

• Development of product and ingredient safety reviews for the Product Safety division, for Medical and Regulatory submissions through technical and regulatory reports/presentations.

Establishes laboratory investigations, test methods development, and technology evaluation for ingredients, formulations, and end-products.

• Must exhibit an exceptional degree of ingenuity, creativity, and resourcefulness to apply and/or develop highly advanced technologies, scientific principles, theories, and co1ncepts, while professionally developing subordinates to do the same.

·

• Leads and guides team members In Product Safety and Formulation Development in RID projects by working a defined area of technical responsibility, providing tech.nI ical training, and serving as a role model of technical excellence.

Increases and Improves base of proprietary knowledge available to the technical teams by the development of new principles and concept
·

• Facilitates the development and proper functioning of interdepartmental and lntercorporate teams.

Acts as the recognized expert/lead of Toxicology and Clinical studies and uses scientific and technical background along with the key team attributes of commitment, cooperation, communication, and contribution to support CDMO business.

• Serves as a consultant to top management in long-range Swiss-f”t1erlcan planning concerning new or projected areas of technological research and product advancement
·

• Must possess strong understanding of how the skin functions (skin biology) and/or physical chemistry or cosmetic formulation and the relationship between skin and dermatological product types.

• Expertise In general toxicology concepts, with applied knowledge in areas of skin/eye Irritation, skin sensitization, genotoxicity, Immunology, and photo toxicity ;

• Expertise In methodologies used to assess the safety and efficacy of OTC, cosmetic and medical devices / I

• Review, organize and compile safety reports for compliance with: US, Canada, EU and other global regulations, on ingredients or products in specific dossier templates and uploading Information to an intemal database

• Support the execution of the Approval for Product Release process.

Manages team members in the Products Safety division
·

Education and Experience

• Graduate/Terminal Degree in chemistry, engineering, toxlcology, pharmacology or other technical subject is required: PhD with post-doc preferred, Master’s degree will be considered.

• 9
– 15 years of experience In personal care/dermatotogy/cosmetics
·industry with formulation and tech transfer experience, consumer healthcare industries is highly preferred

• Experience In searching scientific literature (Science Journals) and publications and knowledge of compliance requirements and ability to organize requisite data

• Excellent oral and written communication skills are required in order to interact with various levels of personnel within and outside Swiss-American I

• Demonstrated skills In analyzing, reporting and documenting information with attention to detail to ensure no mistakes are made, and establishing corrective actions should mistakes occur.

·

Computer Skills

Knowledge of Microsoft Office Business Suite, email, contact management, accounting, and Internet software.

Benefits:

We value our employees’ time and efforts.

Our commitment to your success is enhanced by our competitive annual salary, an extensive benefits package including paid time off, medical, dental and vision benefits, 401K plan with company match, and future growth opportunities within the company.

Plus, we work to maintain the best possible environment for our employees, where people can learn and grow with the company.

We strive to provide a collaborative, creative environment where each person feels encouraged to contribute to our processes, decisions, planning, and culture.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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