Solmax Tablet Uses Jobs in Usa

Job Title - Training Coordinator - Pharma Operations

Location - Easton PA

The Training Coordinator is responsible for the strategic coordination, compliance oversight, and administrative management of the employee development program within pharmaceutical operations or GMP‑regulated training. The Training Coordinator role require candidates with GMP‑regulated experience in a pharmaceutical setting. This role ensures training activities are aligned with operational demands, properly resourced, and fully compliant with company policies, OSHA standards, client requirements, and regulatory expectations. The training coordinator will maintain an audit-ready workforce ensuring employees are compliant and up to date on training records.

MUST HAVES -

• Direct experience maintaining training records in an LMS - need for accurate, audit‑ready training documentation.
• Demonstrated history of developing and delivering internal training in pharma & life sciences, as well as supporting SOP and job aid updates in regulated environments.
• Extensive experience in highly regulated FDA/GMP environments, supporting complaint management, audits, and compliance activities.
• Strong reporting skills, including trending, KPI analysis, and preparing audit‑ready materials.
• experience in warehouse‑specific training logistics, such as WMS familiarity, multi‑shift training calendars, and training around warehouse equipment certification (e.g., PIT/Forklift).
• experience with OJT verification workflows or tracking certifications/expiration dates tied to warehouse operations.
• troubleshooting classroom technology (e.g., handheld scanners or tablets used in training).

Education & Experience

• High school diploma or equivalent
• 2+ years of administrative and training coordinator experience, specifically within a background related to pharmaceutical operations or GMP‑regulated training. candidates with GMP‑regulated experience in a pharmaceutical setting.

Responsibilities:

• Develop and maintain comprehensive training schedules across all warehouse departments.
• Support facilitation of training on company policies, SOPs, safety standards, and operational systems (e.g., LMS, WMS/C3).
• Partner with warehouse leadership to ensure structured training programs are consistently executed for new hires and existing associates.

Logistics & Scheduling

• Training calendar coordination: Manage the master training calendar across 1st, 2nd, and 3rd shifts, ensuring training sessions do not disrupt peak shipping and receiving windows.
• Onboarding Logistics: Coordinate onboarding training for new associates, including safety gear (PPE) distribution, badge access, and classroom setup.
• Equipment Certification: Schedule and track practical evaluations and certifications for Powered Industrial Trucks (PIT) and other applicable equipment, ensuring only authorized personnel operate machinery.

Administrative & LMS Management

• Record Integrity: Maintain the training program within the Quality Management System and any required physical training documentation, ensuring every associate has a complete, accurate, and audit-ready training profile.
• Compliance Tracking: Proactively monitor certification and qualification expiration dates (e.g., PIT/Forklift, HazMat, Safety protocols) to prevent compliance gaps or operational disruption.
• SOP Document Control: Coordinate distribution and version control of Standard Operating Procedures (SOPs) to ensure associates are trained on current, approved processes.

Reporting & Auditing

• Audit Support: Prepare and present training documentation during internal audits, client audits, OSHA inspections, and regulatory reviews.
• Productivity Reporting: Generate reports on training completion rates and "Time to Productivity" for new hires to help Operations plan for peak seasons.
• OJT Verification: Collect, verify, and maintain On-the-Job Training (OJT) documentation to confirm hands-on competency validation by authorized supervisors.

Technical Skills:

• Advanced proficiency in Microsoft Office (Excel is critical for tracking metrics). Experience with Quality Management Systems and/or Warehouse Management Systems is a plus.
• Organization: Exceptional organizational skills with a "zero-error" approach to data entry, understanding that a missing record can lead to a regulatory finding.
• Communication: Ability to communicate clearly within a diverse workforce, from entry-level associates to senior facility management.
• Experience with "Train-the-Trainer" models in a manual labor setting.
• Ability to troubleshoot basic classroom technology (tablets, hand-held scanners used for training).
• Effective analytical, problem solving and decision-making skills (can gather and analyze data and information and draw conclusions). Able to think logically and analytically.
• Able to prioritize, organize tasks and time, and follow up. Performs responsibilities efficiently and timely. Able to balance multiple requests and meet deadlines.
• Able to work well in a team environment and as part of a team.
• Demonstrates ability to effectively lead a team to successful completion of a project.
• Knowledge of FDA and CFR requirements surrounding training

Location: This person must be based in North, GA or the metro Atlanta area.

About Us:

SOLMAX is a leading provider of innovative geosynthetic solutions in the geotextile and geomembrane industry. Our products play a crucial role in various applications, including civil engineering, environmental protection, and construction projects. We are dedicated to delivering high-quality materials to our customers while maintaining a strong focus on sustainability and innovation.

Position Overview:

As an Indirect Category Manager in the Geotextile and Geomembrane Industry at SOLMAX, you will have a vital role in overseeing the procurement and management of all indirect materials and services that support our operations. We are searching for an initiative-taking and experienced professional who can leverage their expertise in category management, negotiation, and knowledge of the geosynthetics market to optimize indirect spend categories and contribute to our ongoing success.

Key Responsibilities:

• Category Management: Assis in designing, developing and implementation of comprehensive category strategies for all indirect spend categories, ensuring alignment with the company's objectives and targets.
• Supplier Management: Identify, evaluate, and manage supplier relationships across various indirect categories, focusing on cost efficiency, quality improvement, and innovation.
• Negotiation: Utilize strong negotiation skills to secure favorable terms, pricing, and contracts with indirect category suppliers while maintaining quality standards.
• Contract Management: Strong contract management expertise, with firsthand experience in redlining, editing, and negotiating terms and conditions to protect the business and ensure favorable outcomes.
• KPI’s: Establish reporting mechanisms to track and realize savings.
• Cost Optimization: Implement cost reduction initiatives and process improvements to enhance cost competitiveness across indirect categories.
• Market Analysis: Continuously monitor industry trends, market conditions, and competitive landscape related to indirect categories to make informed decisions.
• Risk Management: Proactively identify and mitigate supply chain risks associated with indirect materials and services to ensure operational continuity.
• Quality Assurance: Collaborate with relevant teams to maintain and improve the quality and efficiency of services and materials within the indirect categories.
• Compliance: Ensure adherence to all relevant regulatory and compliance requirements for indirect procurement.

Qualifications:

• A bachelor's degree in Supply Chain, Finance or relevant field

Experience:

• A minimum of 5+ years of indirect category management experience, preferably in the manufacturing industry.
• Exceptionally strong negotiation skills and a proven record of successfully negotiating favorable agreements in indirect categories.
• Excellent analytical and critical thinking skills.
• Proficiency in supply chain management software, Spend Analytics, Excel, Tableau, Power BI and Microsoft Office Suite.
• Effective communication and people skills. Proven history of leading cross functional teams
• Ability to work effectively both independently and as part of a team.
• A commitment to upholding ethical and professional standards.
• Experience in ERP platforms: Dynamics365, SAP, AS400 is a plus.

Indirect Categories Managed (Candidate NEEDS to have experience with the following):

• Maintenance, Repair, and Operations (MRO)
• Utilities
• Temporary Labor
• Capital Expenditures
• Leasing Agreements

Overview

SOLMAX is a world-leading manufacturer of geomembrane and geotextile products. With a strong commitment to quality and innovation, we provide sustainable solutions for various industries including construction, environmental protection, and agriculture. We are dedicated to creating a positive impact on the planet and are looking for passionate individuals to join our team.

Position Overview: As a Buyer I at SOLMAX, you will play a key role in our procurement team, responsible for purchasing materials to support our manufacturing operations at single site level. You will collaborate closely with internal stakeholders to ensure that we maintain optimal inventory levels while adhering to quality standards and budgetary constraints.

Key Responsibilities

• Purchase MRO, components, and services required for manufacturing operations.
• Reconcile invoices, requisition and receipts.
• Collaborate with internal stakeholders to understand requirements and develop procurement strategies.
• Monitor inventory levels and ensure timely replenishment to avoid stockouts.
• Evaluate supplier performance and address any issues or concerns.
• Maintain accurate records of purchases, pricing, and supplier information.
• Stay up to date with industry trends and market conditions to identify opportunities for cost savings and process improvements.

Qualifications

• Bachelor's degree in Business Administration, Supply Chain Management, or related field.
• 1-2 years of experience in procurement or supply chain management, preferably in a manufacturing environment.
• Strong negotiation skills and ability to build effective relationships with suppliers.
• Excellent communication and interpersonal skills.
• Proficient in Microsoft Office Suite and ERP systems

Build a Career That Matters with One of the World's Most Respected Employers!

- - - - - - - - - - - -

Tablet is how you book the world's most exciting hotels - places where you get a memorable experience, not just a room for the night. For over 20 years we've scoured the earth to find hotels that stand out for their style, service, and personality - regardless of price. In fact, our painstaking curation led to Michelin making us the official hotel selection of their legendary MICHELIN Guide. The MICHELIN Guide has always been a benchmark in gastronomy. Now it's setting the same standard for hotels.

Our mission is to open doors to places people will love that they might not have found on their own, extraordinary places that reflect the beauty and diversity of the world. Our team believes that travel brings people of all backgrounds together. Our hotels provide an unforgettable backdrop for that union.

Headquartered in New York City, we operate in eight languages, bringing the top 1% of hotels in over a hundred different countries around the world to our discerning clientele via our website and app. And if you really want to take it to the next level, our Plus membership program provides VIP upgrades and amenities at hundreds of our properties.

Travel Specialist (Bilingual English & French)

The Customer Service team is responsible for maintaining Tablet's reputation for having the best customer service in the online travel agency business. As the face of the company our Travel Specialists' mission is to create a customer experience so incredible it defines the brand.

Travel Specialists convert new users into loyal customers, keep existing customers coming back for more, quickly and confidently minimize damage (regardless of the source) while demonstrating resourcefulness and grit, and are able to predict and get ahead of conflicts.

As a Travel Specialist you'll assist our clients across the Tablet Hotels and MICHELIN Hotel brands via phone, email, and live chat with hotel reservations, hotel recommendations, rate and availability searches, technical support, special requests, and feedback. You'll also be an ambassador of our Tablet Plus program. Additionally, up to 25% of the role will be dedicated toward restaurant inquiries for the MICHELIN Guide.

Maintaining an incredible customer experience requires timely and concise communication between clients and hotel partners with an ability to manage expectations in a high-volume and collaborative setting. Our ideal candidate has a sincere desire to ensure our clients' needs are satisfied quickly and simply.

Requirements:

• Superb oral and written communication in English and French

• Customer-facing experience in travel, hospitality, or related luxury industries

• Proficiency with Google Workspace or other cloud-based document creation and collaboration platforms

• Experience communicating over chat platforms like Slack in tandem with email and phone

Travel Specialists are asked to work at least two paid holidays per calendar year. Occasionally, you may need to work past the end of your shift to complete tasks because the world of travel doesn't stop when we do.

This is a hybrid role requiring one day per week in our New York City office. The starting schedule for this role is Thursday - Monday 1pm - 10pm ET.

$78k Annual Salary

Ready to Shape the Future of Innovation?

Michelin is building a world-leading manufacturer of life-changing composites and experiences. Pioneering engineered materials for more than 130 years, Michelin is uniquely positioned to make decisive contributions to human progress and a more sustainable world. Drawing on its deep know-how in polymer composite materials, Michelin is constantly innovating to manufacture high-quality tires and components for critical applications in demanding fields as varied as mobility, construction, aeronautics, low-carbon energies and healthcare.

The care placed in its products and deep customer knowledge inspire Michelin to offer the finest experiences. This spans from providing data- and AI-based connected solutions for professional fleets to recommending outstanding restaurants and hotels curated by the MICHELIN Guide.

Why Michelin?

• Career Growth: Personalized development plans, mentorship, and cross-functional opportunities. Unique career paths and opportunities for advancement.

• Inclusive Culture: Thrive in a diverse, supportive environment where your competencies, contributions and behaviors are recognized. Option to join one of our Connected Communities.

• Innovation-Driven: Work on projects that matter-from sustainable materials to digital transformation.

• Community Impact: Be part of a company that does what's right. We use sustainable business practices while balancing the needs of our customers and communities.

Michelin provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), political affiliation, military service, or other non-merit-based factors. Consistent with these obligations, Michelin also provides reasonable accommodations to employees and applicants with disabilities and for sincerely held religious beliefs. If you need accommodation for any part of the employment process because of a disability, please contact us at .

This position is not available for immigration sponsorship.

We build the future with people like you. Begin your career with Michelin today!

**This territory spans from Valley Stream to Massapequa and the surrounding areas**

Phathom Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of gastrointestinal (GI) diseases. With exclusive rights in the United States, Europe, and Canada to vonoprazan—a first-in-class potassium-competitive acid blocker (PCAB)—Phathom is working to transform the treatment of acid-related disorders.

Our Current Portfolio Includes

• VOQUEZNA® (vonoprazan) tablets, approved for the treatment of heartburn associated with Non-Erosive GERD, as well as the healing and maintenance of healing of Erosive GERD
• VOQUEZNA® TRIPLE PAK® (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA® DUAL PAK® (vonoprazan tablets, amoxicillin capsules), approved for the treatment of H. pylori infection in adults

Beyond our commercialized products, we are advancing a pipeline focused on innovative treatments for other acid-related GI disorders, including Eosinophilic Esophagitis (EoE).

At Phathom, we are fueled by innovation, driven by purpose, and united by a shared commitment to improving patient outcomes. Our team comprises seasoned GI and industry experts with proven track records of delivering groundbreaking therapies, including anti-secretory agents. Together, we are tackling unmet medical needs and working hard to enhance the lives of patients.

We seek motivated, innovative problem-solvers who excel in fast-paced, collaborative environments and are eager to make an impact. At Phathom, you’ll find more than a career – you’ll join our “Phamily,” where employees feel empowered, valued, and inspired to do their best work.

In July 2025, we proudly earned the distinction of being Great Place to Work® certified, with 89% of surveyed employees affirming that Phathom is an exceptional workplace.

Ready to help change the landscape in GI? Join us and be part of something extraordinary.

Job Summary

The Territory Sales Representative has a responsibility to meet and exceed sales objectives in their assigned geography while in accordance with all applicable company and regulatory standards. The territory sales representative will work to understand and identify customer needs, aligning appropriate resources and all pull through activities. The territory sales representative will acquire advanced product and disease state knowledge that allows for in-depth engagement with all health care professionals. Reporting to the Regional Sales Manager, this individual will promote the company's first ever product calling on Gastroenterologists, Advanced Practice Practitioners (APPs) and select Primary Care Physicians in assigned territory to achieve sales goals. The territory sales representative will work closely with peers, Regional Sales Managers, and commercial colleagues to achieve territory, region, and corporate goals.

Essential Job Responsibilities

Responsibilities will include, but are not limited to, the following:

• Drives sales performance to ensure sales goals are met or exceeded.
• Maintain advanced product and disease state expertise to effectively engage Gastroenterologists, Primary Care Physicians, APPs, and office-staff delivering clinically focused messages introducing a new treatment option and overcoming objections.
• Continuously builds understanding of territory market dynamics and market access opportunities accelerating pull through by effectively communicating with HCPs and office staff.
• Works closely with Regional Sales Manager and Strategic Account Specialists (SAS) to effectively develop territory business plans to achieve sales goals.
• Works with peers, marketing, training, and sales operations driving operational execution and sharing best practices.
• Meets all administrative management responsibilities including effective use of CRM, and expense reporting.

Qualifications

• Bachelor’s degree from an accredited college or university
• Two years or more of successful medical sales experience (e.g., dental, medical device, laboratory, diagnostics) or one year pharmaceutical sales experience; GI Specialty experience preferred
• Proven and consistent track record of success in sales performance
• Experience launching new products
• Demonstrated success leveraging all resources (marketing, market access pull through and technology solutions).
• Proven business acumen and analytical expertise
• Builds professional relationships with office staff and others in the customer network
• Demonstrated success in both live and virtual interactions.
• Ability to work in a fast paced, dynamic work environment
• Strong technical skills, computer proficiency with Microsoft Office Suite including Excel, PowerPoint and digital meeting platforms including Veeva Engage, Teams, Zoom etc.
• Valid driver’s license and safe driving record
• Some territory overnight travel may be required depending on geography
• Travel to national, regional, and corporate office may be required

Phathom’s Core Values

• Perseverance – With hard work and determination, together we overcome all obstacles
• Humble – We put others first, remain grounded and let our work speak for itself
• Accountable – We are reliable and take personal responsibility in all that we do. We take pride and ownership in our work every day
• Transparent – We say what we mean, debate openly and respectfully, and have no hidden agendas
• Entrepreneurial – We are nimble, agile and embrace innovation. We challenge the status quo, enjoy change and approach problems unconventionally

Working At Phathom

At Phathom, we prioritize the total well-being of our “Phamily” members. Our commitment is reflected in a competitive employee benefits package designed to support employees and their families’ overall well-being, now and in the future, including:

• Highly competitive medical, dental and vision coverage options with low monthly premiums
• Roth & Traditional 401(k) savings plan with annual employer match
• Long-term incentive equity compensation program
• Employee Stock Purchase Plan (ESPP)
• Comprehensive paid leave programs, including:
• 16 weeks of paid parental leave for all new parents
• 4-week part-time Bridge-Back-to-Work Program
• Hybrid and Flex Working Arrangements
• Unlimited Time Off
• 17 paid company holidays in addition to a year-end winter shutdown period

Other Benefits

• Annual Fitness & Wellbeing Reimbursement
• Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance
• Company-provided short and long-term disability benefits
• Pet insurance benefits
• Company-funded HSA plan
• Accident and Hospital Indemnity insurance
• Employee Assistance Program (EAP)
• Paid time off to volunteer
• Employee recognition program
• Employee discounts

The expected annual base salary range for this role is $90,000 - $140,000.

Phathom is an equal opportunity employer that is committed to inclusion and diversity and provides equal opportunity for all applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, Veteran status, or other legally protected characteristics.

Applicants with a disability who require a reasonable accommodation for any part of the application, interview or hiring process can contact us by sending an email to

**This territory spans from Valley Stream to Massapequa and the surrounding areas**

Phathom Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of gastrointestinal (GI) diseases. With exclusive rights in the United States, Europe, and Canada to vonoprazan—a first-in-class potassium-competitive acid blocker (PCAB)—Phathom is working to transform the treatment of acid-related disorders.

Our Current Portfolio Includes

• VOQUEZNA® (vonoprazan) tablets, approved for the treatment of heartburn associated with Non-Erosive GERD, as well as the healing and maintenance of healing of Erosive GERD
• VOQUEZNA® TRIPLE PAK® (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA® DUAL PAK® (vonoprazan tablets, amoxicillin capsules), approved for the treatment of H. pylori infection in adults

Beyond our commercialized products, we are advancing a pipeline focused on innovative treatments for other acid-related GI disorders, including Eosinophilic Esophagitis (EoE).

At Phathom, we are fueled by innovation, driven by purpose, and united by a shared commitment to improving patient outcomes. Our team comprises seasoned GI and industry experts with proven track records of delivering groundbreaking therapies, including anti-secretory agents. Together, we are tackling unmet medical needs and working hard to enhance the lives of patients.

We seek motivated, innovative problem-solvers who excel in fast-paced, collaborative environments and are eager to make an impact. At Phathom, you’ll find more than a career – you’ll join our “Phamily,” where employees feel empowered, valued, and inspired to do their best work.

In July 2025, we proudly earned the distinction of being Great Place to Work® certified, with 89% of surveyed employees affirming that Phathom is an exceptional workplace.

Ready to help change the landscape in GI? Join us and be part of something extraordinary.

Job Summary

The Territory Sales Representative has a responsibility to meet and exceed sales objectives in their assigned geography while in accordance with all applicable company and regulatory standards. The territory sales representative will work to understand and identify customer needs, aligning appropriate resources and all pull through activities. The territory sales representative will acquire advanced product and disease state knowledge that allows for in-depth engagement with all health care professionals. Reporting to the Regional Sales Manager, this individual will promote the company's first ever product calling on Gastroenterologists, Advanced Practice Practitioners (APPs) and select Primary Care Physicians in assigned territory to achieve sales goals. The territory sales representative will work closely with peers, Regional Sales Managers, and commercial colleagues to achieve territory, region, and corporate goals.

Essential Job Responsibilities

Responsibilities will include, but are not limited to, the following:

• Drives sales performance to ensure sales goals are met or exceeded.
• Maintain advanced product and disease state expertise to effectively engage Gastroenterologists, Primary Care Physicians, APPs, and office-staff delivering clinically focused messages introducing a new treatment option and overcoming objections.
• Continuously builds understanding of territory market dynamics and market access opportunities accelerating pull through by effectively communicating with HCPs and office staff.
• Works closely with Regional Sales Manager and Strategic Account Specialists (SAS) to effectively develop territory business plans to achieve sales goals.
• Works with peers, marketing, training, and sales operations driving operational execution and sharing best practices.
• Meets all administrative management responsibilities including effective use of CRM, and expense reporting.

Qualifications

• Bachelor’s degree from an accredited college or university
• Two years or more of successful medical sales experience (e.g., dental, medical device, laboratory, diagnostics) or one year pharmaceutical sales experience; GI Specialty experience preferred
• Proven and consistent track record of success in sales performance
• Experience launching new products
• Demonstrated success leveraging all resources (marketing, market access pull through and technology solutions).
• Proven business acumen and analytical expertise
• Builds professional relationships with office staff and others in the customer network
• Demonstrated success in both live and virtual interactions.
• Ability to work in a fast paced, dynamic work environment
• Strong technical skills, computer proficiency with Microsoft Office Suite including Excel, PowerPoint and digital meeting platforms including Veeva Engage, Teams, Zoom etc.
• Valid driver’s license and safe driving record
• Some territory overnight travel may be required depending on geography
• Travel to national, regional, and corporate office may be required

Phathom’s Core Values

• Perseverance – With hard work and determination, together we overcome all obstacles
• Humble – We put others first, remain grounded and let our work speak for itself
• Accountable – We are reliable and take personal responsibility in all that we do. We take pride and ownership in our work every day
• Transparent – We say what we mean, debate openly and respectfully, and have no hidden agendas
• Entrepreneurial – We are nimble, agile and embrace innovation. We challenge the status quo, enjoy change and approach problems unconventionally

Working At Phathom

At Phathom, we prioritize the total well-being of our “Phamily” members. Our commitment is reflected in a competitive employee benefits package designed to support employees and their families’ overall well-being, now and in the future, including:

• Highly competitive medical, dental and vision coverage options with low monthly premiums
• Roth & Traditional 401(k) savings plan with annual employer match
• Long-term incentive equity compensation program
• Employee Stock Purchase Plan (ESPP)
• Comprehensive paid leave programs, including:
• 16 weeks of paid parental leave for all new parents
• 4-week part-time Bridge-Back-to-Work Program
• Hybrid and Flex Working Arrangements
• Unlimited Time Off
• 17 paid company holidays in addition to a year-end winter shutdown period

Other Benefits

• Annual Fitness & Wellbeing Reimbursement
• Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance
• Company-provided short and long-term disability benefits
• Pet insurance benefits
• Company-funded HSA plan
• Accident and Hospital Indemnity insurance
• Employee Assistance Program (EAP)
• Paid time off to volunteer
• Employee recognition program
• Employee discounts

The expected annual base salary range for this role is $90,000 - $140,000.

Phathom is an equal opportunity employer that is committed to inclusion and diversity and provides equal opportunity for all applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, Veteran status, or other legally protected characteristics.

Applicants with a disability who require a reasonable accommodation for any part of the application, interview or hiring process can contact us by sending an email to

About the Company

At SFI Health, we believe we have the responsibility to bring proven natural health solutions to people’s healthcare needs. We are a global natural health company committed to sourcing and producing natural medicines to the highest standards. Backed by evidence of effectiveness, quality and safety, our products are marketed around the world using our international community of leading life sciences companies and distributor networks. To find out more, please visit the Role

Essential job functions:

Leadership/Team Management

• Working to establish and maintain company goals, budgets, strategies, vision, culture, and direction
• Working with cross functional teams to provide input on sourcing, quality control testing, regulatory and production teams by clearly communicating product capabilities, constraints and design trade offs.
• Providing feedback on new product concepts and feasibility of manufacturing
• Responsible for direct reports training and development
• Coaching product development team to achieve high performance
• Development and maintenance of departmental performance measurements

Product Development and Formulation Management

• Develop formulations for a variety of oral, solid dosage delivery forms (i.e., capsules, tablets, powders)
• Work with Purchasing/supply chain to source raw materials that meet quality and regulatory requirements
• Work with Purchasing and Regulatory to qualify vendors and raw materials
• Perform process improvements and analyze formulas for reformation
• Coordinate and execute bench work, pilot production, and manufacturing scale up
• Create and maintain formulation parameters for qualified raw materials (bulk density, moisture, particle sizes, etc.)
• Provide guidance to development team and project management to achieve launch timelines
• Assist team members in troubleshooting manufacturing issues tied to formulation
• Provide technical assistance towards analytical and microbiological test methods and testing plans

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Education:

• Advanced Degree preferred in Pharmacy, Chemistry, Food Science, Chemical Engineering or other related science background

Experience:

• Experience with Quality Management Systems, SAP software, and project management software desired
• 10+ years industry formulation development
• 10+ years managing staff or teams or,
• Combination of education and experience
• Working knowledge of solid dose form equipment such as tablet presses, tablet coating encapsulation machines, and granulation processes
• Comprehensive knowledge and practical experience with product/process development, processing laboratory techniques and regulatory requirements

Skills & abilities:

• Strong organizational skills and the ability to work in a team environment
• Proven leadership and multi-tasking skills
• Demonstrated ability (and passion) to thrive in an often chaotic and rapidly changing environment.
• Creative problem solving and negating skills
• Excellent verbal communication skills with the ability to translate complex product attributes, limitations and value propositions into clear customer focused explanations.

Technical/Functional Skills

• Demonstrates excellent communication skills, both written and verbal, and communicates clearly in all situations
• Translates organizational goals and objective into actionable plans
• Prioritizes work to meet multiple deliverables and deadlines
• Assesses and drives improvement in employee performance by providing clear, attainable goals, actionable coaching feedback and maintaining clear, detailed, written documentation
• Identifies performance and career development needs in team members and works with the employee to prepare an effective development plan
• Serves as an effective subject matter expert to cross-functional teams
• Thinks strategically to find and implement new and better solutions

Computer skills:

• Microsoft Office suite
• Database management

Supervisory Responsibilities:

This position supervises the following positions:

• Document Specialist – PD
• R&D Analyst (2)
• Manager, Product Development

JOB OVERVIEW:

The Validation Scientist position encompasses all areas of Technical Services with primary focus on technology transfer, scale-up, process optimization, process/packaging validation, commercial production technical support as well as equipment qualification and cleaning validation support.

KEY ROLES/RESPONSIBILITIES:

• Lead and execute projects such as technology transfer, scale-up, process optimization process/packaging validation as well as equipment qualification and cleaning validation support to meet critical project deadlines.
• Provide technical support in the investigation of manufacturing incidents and major deviations. Assure thoroughness of investigation and documentation as well as implementation of preventive/corrective actions as necessary.
• Conduct commercial production technical support activities such as qualification of alternate suppliers of API, excipients and packaging components, equipment change parts, process parameters, yield limits, hold time studies, etc.
• Execute utility and process equipment qualification support activities such as installation, operational and performance qualifications, periodic reviews, investigations, assessments, review change control and non-routine maintenance requests, out of specification calibrations, etc.
• Perform cleaning validation support activities such as execution of cleaning validation and verification studies, hold time studies, investigations, assessments, justifications, maintain cross contamination program, etc.
• Develop and/or execute experimental designs and approaches to resolve technical problems and utilize engineering standards, principles, concepts, equations as well as statistical techniques.
• Prepare and review documents to support projects, such as laboratory notebooks, protocols, reports, assessments, justifications, investigation reports, regulatory submissions, master batch records, change control, etc.
• Complete and document physical sampling and testing such as loss on drying, particle size distribution, bulk density, viscosity, pH, tablet weight, thickness, hardness and friability; sample for analytical and microbiological testing.
• Author and periodically update assigned Standard Operating Procedures (SOPs) for the department.
• Represent Technical Services at project team meetings and provide sound technical advice.
• Coordinate and interface with Operations, Facility Engineering, Quality Control, Quality Assurance and Regulatory Affairs groups to assure successful project execution.
• Directly interact with Piramal Pharma Solutions clients.
• Maintain regulatory compliance within the function and follow site safety, health, and environmental policies and procedures.

EXPERIENCE:

• Minimum of a Bachelor's degree in a scientific discipline (e.g., Chemical Engineering, Pharmaceutics, Pharmacy, Chemistry or equivalent) with a minimum of 3 years experience in Technical Services, Process Engineering, Process Validation, Formulation or related field in the pharmaceutical industry.
• Experience in laboratory and production scale manufacture of solid oral, liquid and semi-solid dosage forms using equipment such as comminuting mills, high-shear granulators, fluid bed dryers, blenders, tablet presses, tablet film coaters, encapsulates, low and high-shear mixing vessels, homogenizers, pumps, packaging, etc.
• Working knowledge of cGMP (Current Good Manufacturing Practices) regulations, SUPAC guidance, and general compliance expectations.
• Working knowledge of investigational techniques, including but not limited to root cause analysis, risk assessment impact evaluation, and technical report writing.
• Must possess research and problem solving abilities and be capable of producing detailed documentation, understand and make generalized and specific conclusions from project data.
• Technical writing experience is required with attention to detail skills essential.
• Must be able to work in a team environment with effective project planning/management, analytical thinking, organization, and execution skills.
• Must have proficiency in the Microsoft Office Suite programs.
• Demonstrated professionalism and excellent communication skills with internal and external personnel are essential.
• Ability to work effectively managing multi projects at a fast pace withcross-functional departments and manage priorities to meet timelines.
• Must be innovative, proactive, resourceful and committed to continuous improvement.
• Working knowledge of cGMP data management systems (EDMS, Trackwise, and/or SAP) is preferred.

WORK ENVIRONMENT:

The position requires the ability to work in ahigh demand office and manufacturing setting with time spent performing "on the floor" activities in laboratory and manufacturing areas. The position may require extended hours including evenings and weekends as well as work hours on 2nd and 3rd shifts depending on project needs.