Frontida is actively recruiting innovative and caring professionals. Here, you can help develop and build a culture of caring, accountability and continuous improvement (both individually and corporately). Frontida careers extend from pharmaceutical formulation scientists to quality assurance specialists, information technology to regulatory compliance professionals, and manufacturing to mechanical specialists. Join a powerful, results-oriented team.

Job Summary

This position is for our manufacturing facility in Aurora, IL.

We are seeking a Manager of Manufacturing to join our team! You will oversee the activities of a team of production workers. 

Responsibilities

  • Manages staff and carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, terminating and training employees; planning, assigning, and directing work; appraising performance; counseling employees; addressing complaints and resolving problems.
  • Organize shift schedule to meet production demands. Use and Maintain electronic schedule using Microsoft Project Central or similar tool.
  • Assign operators job responsibilities on daily basis
  • Ensure that necessary materials and supplies are available to facilitate the operators completion of daily job responsibilities.
  • Ensure that operators’ actions are consistently performed with a “safety” minded attitude and are within guidelines determined by cGMP, SOP and Company policy.
  • Support, direct and train operators during the performance of their daily job responsibilities. Support, direct and train materials management personnel during the performance of their daily job responsibilities. Use Electronic Inventory Management and Batch Planning tools as required.
  • Evaluate, review and audit operators performance and work environment for “safety”, cGMP, SOP and Company policy compliance.
  • Work with the maintenance department in order to ensure that the process equipment and supporting machinery are properly maintained. Generate maintenance work tickets as required.
  • Work with the Quality Department to ensure that Quality issues are resolved in a timely manner. Use Electronic Quality Management systems as directed by SOP.
  • Ensure that the BMR (Batch Manufacturing Records) are completed on time and correctly.
  • Must participate and successfully complete all training as required by the company. Create, modify and maintain SOP’s for manufacturing activities.
  • Assist in authoring and reviewing Process Development reports, BMR’s and Protocols.
  • Perform other duties as assigned.

Qualifications

  • B.S. degree in Business, Pharmacy, Chemistry, Engineering with 2+ years’ pharmaceutical manufacturing experience or equivalent combination of education, training and experience.
  • Ability to operate related manufacturing equipment.
  • Proficient in Microsoft Office applications (Word, Excel, Outlook) and business related application packages highly desired, plus the ability to learn company used applications
  • Strong leadership qualities
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Proficiency in relevant software (i.e., MS Word, MS Office or similar systems, Adobe) and business related application packages highly desired, plus the ability to learn company used applications
  • High degree of professionalism, ethics and integrity
  • Incumbent must be able to be accountable for own actions and decisions and is in compliance of the laws and company policies.
  • Willing to participate in our group identity characterized by commitment, trust, and care for each other.
  • Willing to invest time and energy in continuous improvement efforts

Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status or any other characteristic protected by law.

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

Compliance Specialist is responsible for administering GMP computer systems used in Quality Control and support computer systems validation projects. Time permitting, also support Compliance department responsibilities including but not limited to vendor qualification program, annual product reviews, internal audits, metrics collection across the company, and preparing for monthly quality council/management review meetings.

 

 

EDUCATION, SKILLS AND/OR EXPERIENCE

Responsibilities

Primary Responsibilities

  • Primary administrator for computer systems used in QC, such as Empower and stand alone instruments
  • Primary administrator for MasterControl company wide document/training/event management software
  • Support Manager Computer Systems Validation in generating/executing computer systems validation documents
  • Prepare change control documentation related to troubleshooting and preventive maintenance activities related to system administration responsibilities
  • Review existing computerized systems for compliance to company procedures, computer validation requirements, data integrity and 21 CFR Part 11 compliance as assigned
  • Write/Review/Update SOP’s related to computer systems in QC and MasterControl
  • Performs internal audits to ensure compliance against procedures and regulations

Support additional Compliance Department responsibilities as time allows:

  • Collects metrics across the company for trending of quality performance
  • Performs annual and quarterly trend reports
  • Authors and reviews Annual Product reviews
  • Performs external audits for suppliers and service providers
  • Manages the vendor qualification program
  • Provides support for execution of special quality projects to implement quality systems improvements to meet regulatory requirements
  • Provides support during FDA and other regulatory body inspections
  • Updates Standard Operating Procedures (SOP)

Supports other department as directed which may include:

  • Assigns and communicates corrective and preventive actions (CAPA) to responsible departments based on root cause analysis

Qualifications

  • Bachelors degree in life science such as Chemistry, Microbiology or related scientific field
  • 2-4 years Quality experience in the pharmaceutical industry
  • Experience with Computer System Validation following GAMP desired
  • Some knowledge of cGMP and FDA regulations
  • Proficient in the use of Microsoft Office applications (Word, Excel, Outlook, Access) and business related application packages
  • Experience with TrackWise, MasterControl or similar Quality Event Management software preferred

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

The Compliance Specialist  will be responsible for managing the vendor qualification program, conducting performing annual product reviews, collecting metrics across the company, and preparing reports for monthly quality council/management review meetings and other technical reports common to the Compliance Department.

Responsibilities

  • Collects metrics across the company for trending of quality performance
  • Performs annual and quarterly trend reports
  • Authors and reviews Annual Product reviews
  • Performs internal audits to ensure compliance against procedures and regulations
  • Performs external audits for suppliers and service providers
  • Manages the vendor qualification program
  • Provides support for execution of special quality projects to implement quality systems, improvements to meet regulatory requirements
  • Provides support during FDA and other regulatory body inspections
  • Updates Standard Operating Procedures (SOP)
  • Supports other departments as directed which may include:
    • Conducts investigative analysis of non-conformance events in the Quality Control laboratory
    • Assigns and communicates corrective and preventive actions (CAPA) to responsible departments based on root cause analysis

Qualifications

  • Bachelors Degree in a lie science such as Chemistry, Microbiology, Biology or related scientific field supplemented with 2-4 years Quality Experience in pharmaceutical industry.
  • Some knowledge of cGMP, FDA and OCHA regulations.
  • Proficiency in Microsoft Office applications (Word, Excel, Outlook, Access) and business related application packages.
  • Experience with Quality Event Management software

 

Knowledge and Skills

  • Strong analytical skills, with an ability to use scientific knowledge and statistical methods to identify potential problems and trends.
  • Ability to organize and write scientific reports
  • Good project management skills
  • Strong computer skills and knowledge of word processing software and spreadsheet software
  • Competent in leading meetings, investigations and team projects
  • Competent in pharmaceutical compliance and regulatory policies
  • Knowledge of pharmaceutical industry guidelines, trends and practices
  • Act with professionalism and treat others with respect and consideration regardless of their status or position
  • Ability to gather information from multiple sources and coordinate and analyze their impact on each other
  • Previous completion of cGMP training

 

Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status or any other characteristic protected by law.

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

Job Summary

We are seeking associate analytical scientist to join our Analytical R&D team at our Philadelphia location. This is a laboratory-based position and the candidate will be responsible to support formulation development by performing analytical testing and assisting in analytical method development and validation activities for both ANDA and NDA projects

Responsibilities

Responsibilities

  • Conduct and document chemical and physical testing of finished products, raw materials, API, in-process products, stability samples to support new product formulation development for both ANDA and NDA projects
  • Participate in analytical method development
  • Conduct and document method verification, method transfer, and method validation as per approved method validation protocols, Company SOPs and ICH Guidance
  • Conduct and document in-process and finished product testing for product release and stability as per the approved test methods
  • Effectively communicate with cross functional teams like Formulation Development, Quality Control, Quality Assurance, Compliance and Regulatory Affairs
  • Attend SOP, Safety and scientific training’s to remain current with cGMP regulations, and safety standards
  • Follow relevant Frontida SOP’s and FDA/ICH guidance
  • Other duties as assigned

Qualifications

Qualifications:

  • MS in Chemistry or related major with 0-2 years of experience or a BS degree with 0-3 years’ experience is preferred. Experience with generic drug analysis is desirable.
  • Good understanding of chemical and physical analysis principles, knowledge and experience in chromatography analysis, UV, IR, and dissolution is preferred.
  • Fundamental understanding of GMP, ICH and FDA compliance is preferred.
  • Good written and oral communication skills and interpersonal skills.

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

Job Summary

We are seeking analytical Scientists to join our Analytical R&D team at our Philadelphia location. This is a laboratory-based position and the candidate will be responsible to support formulation development by performing method development, validation, writing protocols and reports, conducting chemical and physical testing activities for both ANDA and NDA projects.

 

 

Responsibilities

Responsibilities

  • Develop and evaluate analytical test methods for raw materials and in-process and finished products
  • Write protocols and reports.
  • Conduct and document chemical and physical testing of finished products, raw materials, API, in-process products, stability samples to support new product formulation development for both ANDA and NDA projects
  • Conduct and document method verification and method validation as per approved method validation protocols, Company SOPs, FDA Guidance, and ICH Guidelines
  • Conduct and document in-process and finished product testing for product release and stability as per the approved test methods
  • Effectively communicate with cross functional teams like Formulation Development, Quality Control, Quality Assurance, Compliance and Regulatory Affairs
  • Attend SOP, Safety and scientific training’s to remain current with cGMP regulations, and safety standards
  • Follow relevant Frontida SOP’s and FDA/ICH guidance
  • Other duties as assigned

Qualifications

Qualifications:

  • Ph. D. in Chemistry or related majors with 0-3 years of experience, or a MS degree with 2+ years of experience, or a BS with 5+ years of experience is preferred.
  • Good understanding of chemical and physical analysis principles, experience in method development is preferred.
  • Fundamental understanding of GMP, ICH and FDA compliance is preferred
  • Excellent written and oral communication skills and interpersonal skills

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

We are seeking an experienced scientist to join our Formulation team at our Philadelphia location. This is a laboratory-based position and the candidate will be responsible to support formulation and manufacturing process development by performing formulation development activities for both ANDA and NDA projects.

Responsibilities

  •  Design and develop formulations and processes for new drug products with a focus on oral solids and suspensions for clinical trials, ANDA and NDA projects
  • Utilize experimental design to rapidly optimize formulation composition and in-process specifications
  • Evaluate product testing results, provide next steps for continued development until finalize product formulation and processes
  • Present product development progress to upper management and project teams
  • Write CGMP manufacturing batch record, stability study protocol, in-process and finished product specifications and product development reports
  • Manufacture development, optimization and scale-up batches and submission batches
  • Troubleshoot formulation issues that occur during RD development, scale-ups and/or in production
  • Effectively communicate with cross functional teams like Analytical Development, Quality, PK, Regulatory Affairs and Legal teams
  • Attend SOP, Safety and scientific trainings to remain current with CGMP regulations, safety standards, and development technologies
  • Follow relevant Frontida SOP’s and FDA/ICH guidance
  • Other duties as assigned

Qualifications

  •  Ph.D. in Pharmaceutics, Pharmaceutical Sciences, Chemistry or Chemical Engineering with 0-2 years of experience or a Master’s degree with 3 years’ experience is preferred. Experience with generic drug development is desirable
  • Good understanding of pharmaceutical formulation development principles, QbD, CMC regulation and strong organization skills
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Proficiency in relevant software (i.e., MS Word, MS Office or similar systems, Adobe)
  • High degree of professionalism, ethics and integrity
  • Incumbent must be able to be accountable for own actions and decisions and is in compliance of the laws and company policies.
  • Willing to participate in our group identity characterized by commitment, trust, and care for each other.
  • Willing to invest time and energy in continuous improvement efforts

Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status or any other characteristic protected by law.

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

Summary

We are seeking an Associate Scientist to join our Formulation team at our Philadelphia location. This is a laboratory-based position and the candidate will be responsible to support formulation and manufacturing process development by performing formulation development, scale-up, and validation activities for both ANDA and NDA projects.

 

 

Responsibilities

Essential Functions

  • Assist Formulation Scientists in design and develop of formulations and processes for new drug products, with a focus on oral solids and suspensions for clinical trials, ANDA and NDA projects
  • Assist Formulation Scientists in set-up, operation, and execution of R&D lab experiments
  • Create and follow protocol and batch records in manufacturing development batches
  • Perform laboratory assignments and evaluate testing results
  • Document experiments in lab notebooks, write experimental batch records, stability study protocols, and product development reports
  • Assist in manufacturing of development, optimization, scale-up, and submission batches
  • Help troubleshoot formulation issues that occur during R&D development, scale-ups and/or in production
  • Communicate and present results through oral and/or written updates and formal reports, as needed to internal and external project teams
  • Attend SOP, safety and scientific training’s to remain current with cGMP regulations, safety standards, and development technologies
  • Follow relevant Frontida SOP’s and FDA/ICH guidance
  • Other duties as assigned

Qualifications

Knowledge, Skills and Abilities

  • Bachelor degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biomedical Engineering, Material Science or equivalent with 0-2 years of experience.
  • Knowledge of pharmaceutical formulation development principles, QbD, CMC regulation and organization skills
  • Good interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Proficiency in relevant software (i.e., MS Word, MS Office or similar systems, Adobe)
  • High degree of professionalism, ethics and integrity
  • Incumbent must be able to be accountable for own actions and decisions and is in compliance of the laws and company policies.
  • Willing to participate in our group identity characterized by commitment, trust, and care for each other.
  • Willing to invest time and energy in continuous improvement efforts

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

We are seeking a Lab Software Administrator to join our Analytical R&D team at our Philadelphia location. The Lab software administrator will be responsible for administering lab GMP computer systems used in Analytical R&D lab and help to validate computer system and software. The Lab software administrator will be work with management to upgrade current computer systems and software, to acquire new computer systems and software to keep the Analytical R&D lab up to the current GMP and business requirements. Time permitting, also support other departments, such as QC lab and Compliance department on computer system and software validation and administering.

Responsibilities

Essential Functions

  • Create and maintain user accounts for Empower, Stability System II, Malvern Mastersizer 3000, and software for other stand-alone instruments;
  • Administering Empower servers, LAC/E boxes, and other computers for stand-alone instruments;
  • Resolve software and instrument computer related issues to support analytical testing in a timely manner;
  • Perform data-integrity review for all the lab computers and software per compliance requirements and company SOPs;
  • Create and validate custom fields and reports per the company needs;
  • Work with IT Department on data backup and archiving;
  • Work with Compliance Department on software and computer validation;
  • Lead and coordinator computer/software upgrade and acquisition / installation / qualification/validation of new software and computers for instruments;
  • Write/Review/Approve related SOPs;
  • Review analytical test data per company needs;
  • Help to manage lab documents in MasterControl system;
  • Other duties as assigned.

Qualifications

  • MS or BS in Chemistry, Computer, or other related scientific fields with 2+ years of related experience;
  • Experience with Waters Empower is a must;
  • Experience with Computer System Validation following GAMP desired;
  • Knowledge of cGMP and FDA regulations;
  • Excellent written and oral communication skills and interpersonal skills.

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

The ideal candidate will be able to support branding initiatives and execution, as well as work with the Business Development team to identify, evaluate and finalize partnerships and agreements.

This position will be responsible for supporting short and long-term marketing strategies and programs, such as creating marketing materials, e-newsletters, managing the company website and coordinating industry trade shows.

In addition, this position will have responsibility for supporting the Business Development team with lead generation, client contact and proposal preparation.

Responsibilities

  • Lead execution of marketing strategies and programs to achieve corporate and departmental objectives
  • Prepare and present strategies, programs and budgets to senior management
  • Create Marketing materials, including website content, PowerPoint presentations, brochures and whitepapers
  • Coordinate industry events and trade shows such as (e.g.- DCAT, Bio International, CPhI, AAPS, Contract Pharma)
  • Support Business Development team to drive new sales by leading lead generation and tracking initiatives
  • Develop internal relationships with all departments to generate content for internal and external newsletters
  • Work with marketing agency to increase website traffic through SEO and PPC efforts
  • Perform other duties as applicable

Qualifications

  • Bachelor’s Degree or equivalent
  • 3+ years of experience in the pharmaceutical industry
  • Strong organization skills
  • Strong interpersonal skills including communication, collaboration and negotiation capabilities
  • Excellent oral and written communication skills required
  • To perform this job successfully, an individual must be proficient in each essential duty and the ability to work with minimum supervision

Knowledge and Skills

Language Skills:

Ability to read, analyze, and interpret general business periodicals, professional journals, technical / process procedures, or governmental regulations.  Ability to write reports, business correspondence, and procedure manuals.  Ability to effectively present information and respond to questions from groups of managers.

Computer Skills:

Ability to use PC based software programs (e.g. Microsoft® Word, Excel®, PowerPoint®).

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.