Contact:: (609) Details please visit our website:

Transcription

1 SunGen Pharma aims to create a healthier future for patients while increasing shareholder value through the development and introduction of quality, affordable generic products by experienced, passionate and talented pharmaceutical professionals. SunGen Pharma is a specialty pharmaceutical company focused on development, manufacturing and marketing of high quality generic prescription pharmaceuticals that improve patient's health while creating stakeholder value. We specialize in difficult-to-manufacture and high barrier to entry complex dosage forms, including ophthalmic, injectables, topicals and oral solids. SunGen has Research and Development facilities in Monmouth Junction and Princeton, NJ, and several manufacturing facilities across North America and Asia through partnership and contract manufacturing. SunGen has over 40 products under development at various stages that have been and will be filed with the FDA and Chinese FDA through different partnerships. These products cover multiple dosage forms including oral solids, topicals, and injectables. SunGen Pharma is seeking pharmaceutical licensing, acquisition, and partnership opportunities for ANDA products that are already marketed or currently approved. We also are seeking for joint product development (ANDA, NDA, 505(b)(2)) for US and international markets. support@sungenpharm.com Contact:: (609) Details please visit our website:

2 Open Positions: 1, Formulation Scientist Degree: BS/ MS or above Major in Pharmaceutical related disciplines such as Pharmaceutical Science, Pharmacology, Chemistry, Chemical Engineering 2, Analytical Scientist Degree: BS/ MS or above Major in Chemistry or Life Sciences Location: Princeton Area Junction, NJ 3, Regulatory Affair Associate Degree: BS or Master Major in scientific discipline or equivalent education and experience 4, Business Development Representative Degree: BS or Master Major in Business or related discipline 5, Project Manager Degree: BS or above Major in scientific discipline, Chemistry, Chemical Engineering or a related discipline. 6, Sales Associate Degree: BS or above Major in Sales, Marketing or related discipline

3 1. Formulation Scientist The R&D Formulation Scientist will have the opportunity of working on all aspects of product development cycle for selected drug products, such as identifying/sourcing raw materials, developing formulation and process, and managing product process scale-up, etc. Working on multiple projects simultaneously independently or under the guidance of supervisor, this individual will be responsible for designing experiments to support product development as well as conducting hands-on laboratory and manufacturing process development work. Responsibility Design and conducting formulation and process development studies for injectable and ophthalmic dosage forms. Initiate stability study and pull samples for testing accordingly. Generate/review laboratory data and prepare summary for discussion and conclusions. Write and review technical documents including formulation development protocols and reports, tech transfer report, and other documents. Work with team and transfer manufacturing process to CMO. Write formal reports for inclusion in regulatory filings and support the generation of appropriate responses to questions from regulatory authorities. Maintenance laboratory equipment and instruments Requirements BS, MS /PhD. level in Pharmaceutical related disciplines such as Pharmaceutical Science, Pharmacology, Chemistry, Chemical Engineering. One to five years experience in formulation and process development in a small molecule product environment is preferred. Ability to apply the principles of the basic sciences such as physical and organic chemistry, thermodynamics, and materials science, to formulation development, using a rational, scientific approaches. Experience with formulation and process development for injectable suspension and ophthalmic emulsion products is preferred. Self-motivated, team player and have the ability to work with tight timelines; adapt to changing priorities in a fast paced environment. Knowledge of US FDA registration and ICH Excellent communication skills, interpersonal skills, and problem-solving skills.

4 2. Analytical Scientist The position will be responsible for the development and validation of analytical methodology for the characterization of our injectable/ophthalmic/topical products. validate new analytical methods, conduct stability studies and perform sample testing to support regulatory submissions. Responsibility Support drug product formulation and process development including characterization of the process and finished product. Develop and validate analytical methods. Transfer analytical methodology to CMO/CRO. Generate/review laboratory data, discuss analytical results and conclusions. Review analytical data for completeness and correctness Write formal reports for inclusion in regulatory filings and support the generation of appropriate responses to questions from regulatory authorities. Maintenance laboratory instruments Requirements BS, MS /PhD. level in Chemistry or Life Sciences. One to five years experience in analytical methods development in a small molecule product environment is preferred. Must be knowledgeable in a broad range of instrumentation including HPLC, GC, Ion Chromatography, Mass Spectrometry and wet chemistry Experience with analytical method development and reverse engineering for suspension and topical products is preferred. Has Knowledge of cglp/cgmp as well as ICH guidance Excellent communication skills, interpersonal skills, and problem-solving skills.

5 3. Regulatory Affairs Associate This position is responsible for various regulatory activities to prepare, review and submit high quality regulatory submissions to the health authorities in accordance with regulatory guidelines, applicable federal laws and standards. The associate works with minimum supervision, conferring with more senior staff when indicated. Keep supervisor regularly apprised of project status. Responsibilities: Prepares and review CMC submission documents from regulatory perspective to meet scientific and technical requirements for acceptability and approvability by FDA. Ensure timely and accurate submissions per business objectives and determine deliverables that are aligned with regulatory strategies. Organize the scientific source documents and regulatory documents to support submissions. Author and review the regulatory components of packaging artwork, label copy, advertising, and promotional and educational materials to ensure accuracy and compliance of claims. Support drug regulatory strategies throughout the product development process from drug development to post-marketing surveillance. Interact with functional groups across the organization in the development of relevant data to complete regulatory submissions. Monitor applicable regulatory requirements; assure compliance with internal and external standards and guidance documents. Support the development of regulatory processes for pre-approval compliance activities, submission planning and management. Assist in project-related communications with clinical CRO, CMO, regulatory partners, customs, and governmental authorities. Submission/tracking of all types of clinical regulatory communications. Submission of import/export regulatory documentation. Requirements: BS or MS in scientific discipline or equivalent education and experience. Minimum of 2 years previous work experience in the pharmaceutical industry, preferably in the area of drug regulatory affairs, analytical, QA, R&D or production experience. Must have a working knowledge of US Regulatory Submissions. Has understanding of cgmp and GLP Practices as well as ICH guidance. Experience in labeling regulations, policies, guidelines; hands-on experience in drug labeling, establishment registration, and drug listing preferred. Familiar with regulatory submission publishing and validation; hands-on experience in Adobe Pro, Global Submit, Lorenz Validator preferred. Detail-oriented, highly focused and able to meet deadlines, with excellent verbal and written communication skills. Working knowledge of MS Word, Excel, and other MS Suite applications. Solid interpersonal skills and effective project management ability including the ability to work with teams and handle multiple ongoing projects. Ability to work well under pressure in a dynamic environment.

6 4. Business Development Representative The Business Development Representative function is responsible for contacting and building relationships with new and existing clients, conducting market research and exploring new business opportunities. Responsibilities: Conduct research of potential business partners and opportunities. Create and maintain strong business relationships with new and existing partners, vendors, CMOs and CROs. Stay up to date and current with involved products and product knowledge. Completes required due diligence/monitoring for new and existing business parties. Meet and assist with various presentations to third party. Attend conferences and meetings to introduce the company. Requirements: Bachelor's degree in Business or related discipline from an accredited University Excellent written & verbal communication skills Highly motivated, driven and self-starting individual Strong working knowledge of Microsoft Windows and Windows based systems Comfortable making presentations

7 5. Project Manager The Project Management function is responsible for managing the projects for the Generic Sterile Product Development, Manufacturing, and ANDA Submission. This includes ensuring on time and on budget delivery of projects and acting as a leadership role focal point between CMO and our technical team. This role involves managing the execution of our project requirements with CMO as per an agreed upon program of activities. Responsibilities: Prepare and manage project plan to meet milestones. Proactively evaluate, highlight, and escalate unresolved issues, potential barriers to project progression, and resources constraints to management. Lead meetings to facilitate project completion. Deliver projects within the agreed upon timeline and budget. Communicate project status and highlight critical path activities in a timely manner to management and Business Development. Provide notification of milestone completions for billing to finance. Communicate with supplier, vendor or contractor on project requirements and expectations. Stay current with the regulatory requirements and industry trends for project management. Write plans, engineering drawings, business correspondence, and standard operating procedures. Effectively present information and respond to questions from groups of managers, customers, and regulatory agencies in writing and verbally. Perform all foregoing applying knowledge of project management principles and concepts in a cgmp environment within the pharmaceutical industry. Requirements: Proficient with use of technologies (e.g. Adobe Acrobat, Power Point, Gantt Chart). Strong working experience in generic product development and ANDA submissions. Working knowledge of FDA regulations and applicable FDA guidance. Possess strong attention to details. Excellent multi-tasking skills and ability to manage multiple competing projects while meeting project timelines. Minimum BS in a scientific discipline, Chemistry, Chemical Engineering or a related discipline. 3+ year experience in pharmaceutical project management is required, 5-7 years pharmaceutical product development and/ or manufacturing injectable experience is preferred.

8 6. Sales Associate The Sales Associate is responsible for driving sales to new and existing customers throughout the US and worldwide, supporting sales and marketing manager, following up with clients, monitoring the product cost, supply and demand. Responsibilities: Enthusiastic and innovative approach in marketing and sales strategies. Research and identify potential market/ clients. Identifies marketing opportunities by identifying consumer requirements; defining market, competitor's strengths and weaknesses. Aggressive professional approach to generate/opening new businesses. Firm product knowledge and ability to deliver effective sales pitches to prospective clients. Support sales and marketing manager by tracking and analyzing sales information, report filings. Follow up with clients and develop excellent professional relationship. Sustains rapport with key accounts by making periodic visits/communicate; exploring specific needs; anticipating new opportunities. Monitor the product costs, competitor's prices, supply and demand. Requirements: BA/BS degree in Marketing, Sales, or related discipline. Excellent communications and negotiating skills 1+ years in Sales role; 2+ years in the Health & wellness industry a plus General understanding of the principles of sales Shown creative problem-solving approach and strong analytical skills